CDNA CareDx Inc

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CareDx, Inc. (“CareDx” or the “Company”), together with its subsidiaries, is a leading precision medicine company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients and caregivers. The Company’s headquarters are in Brisbane, California. The primary operations are in Brisbane, California; Omaha, Nebraska; Fremantle, Australia; and Stockholm, Sweden.

The Company’s commercially available testing services consist of AlloSure® Kidney, a donor-derived cell-free DNA (“dd-cfDNA”) solution for kidney transplant patients, AlloMap® Heart, a gene expression solution for heart transplant patients, AlloSure® Heart, a dd-cfDNA solution for heart transplant patients, and AlloSure® Lung, a dd-cfDNA solution for lung transplant patients. The Company has initiated several clinical studies to generate data on its existing and planned future testing services. In April 2020, the Company announced its first biopharma research partnership for AlloCell, a surveillance solution that monitors the level of engraftment and persistence of allogeneic cells for patients who have received cell therapy transplants. The Company also offers high-quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. The Company also provides digital solutions to transplant centers following the acquisitions of Ottr Complete Transplant Management (“Ottr”) and XynManagement, Inc. (“XynManagement”), as well as the acquisitions of TransChart LLC (“TransChart”), MedActionPlan.com, LLC (“MedActionPlan”) and The Transplant Pharmacy, LLC (“TTP”) in 2021, HLA Data Systems, LLC (“HLA Data Systems”) in January 2023 and MediGO, Inc. (“MediGO”) in July 2023.

Testing Services

AlloSure Kidney has been a covered service for Medicare beneficiaries since October 2017 through a Local Coverage Determination (“LCD”) first issued by Palmetto MolDX (“MolDX”), which was formed to identify and establish coverage and reimbursement for molecular diagnostics tests, and then adopted by Noridian Healthcare Solutions, the Company’s Medicare Administrative Contractor (“Noridian”). The Medicare reimbursement rate for AlloSure Kidney is currently $2,841. AlloMap Heart has been a covered service for Medicare beneficiaries since January 2006. The Medicare reimbursement rate for AlloMap Heart is currently $3,240. In October 2020, the Company received a final MolDX Medicare coverage decision for AlloSure Heart. Noridian issued a parallel coverage policy granting coverage for AlloSure Heart when used in conjunction with AlloMap Heart, which became effective in December 2020. In 2021, Palmetto and Noridian issued coverage policies written by MolDX to replace the former product-specific policies. The common policy LCD is titled “MolDX: Molecular Testing for Solid Organ Allograft Rejection” and the associated LCD numbers are L38568 (MolDX) and L38629 (Noridian). The Medicare reimbursement rate for AlloSure Heart is currently $2,753. Effective May 9, 2023, AlloSure Lung is covered for Medicare beneficiaries through the same MolDX LCD (Noridian L38629). The Medicare reimbursement rate for AlloSure Lung is $2,753. Effective April 1, 2023, HeartCare, a multimodality testing service that includes both AlloMap Heart and AlloSure Heart provided in a single patient encounter for heart transplant surveillance, is covered, subject to certain limitations, for Medicare beneficiaries through the same MolDX LCD (Noridian L38629). The Medicare reimbursement rate for HeartCare is $5,993.

On March 2, 2023, MolDX issued a new billing article, with an effective date of March 31, 2023, related to the LCD entitled Molecular Testing for Solid Organ Allograft Rejection (the “Billing Article”). Prior to the Billing Article’s effective date, MolDX informed the affected parties, including CareDx, that enforcement of the revised billing practices outlined in the Billing Article would not be implemented until June 30, 2023. MolDX informed CareDx that its automatic adjudication process would remain in place until June 30, 2023, though claims submitted prior to that date must comply with the applicable LCDs. On May 4, 2023, MolDX issued a revised new billing article with an effective date of March 31, 2023 (the “Revised Billing Article” and together with the Billing Article, the “Billing Articles”). The Revised Billing Article impacts Medicare coverage for AlloSure Kidney, AlloSure Heart and AlloMap Heart and requires certain companies, including CareDx, to implement new processes to address the requirements related to Medicare claim submissions. MolDX has stated that it views the Billing Article as clarifying existing coverage, especially as it relates to when tests are covered in the for-cause and surveillance contexts. MolDX has acknowledged, however, that the Billing Article is a change as it relates to billing more than one test during a single patient encounter. Noridian adopted the Revised Billing Article on August 17, 2023, with a retroactive effective date of March 31, 2023.

Although the Company believes the Billing Articles are inconsistent with the LCDs, Noridian’s and MolDX’s responses to public comments explaining the intended scope of various LCDs, and medical necessity, the Company determined to pause its Medicare reimbursement submissions for AlloSure Kidney commencing on March 7, 2023 to allow the Company further time to evaluate the implications of the Billing Article and update its billing processes for AlloSure Kidney tests by educating clinicians and working with centers to update CareDx’s test order forms to capture the new information required under the Billing Article. Accordingly, the Company did not submit claims for approximately 3,200 AlloSure Kidney tests for Medicare

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reimbursement for the period from March 7, 2023 through March 31, 2023 and did not recognize revenue on these claims in the first quarter of 2023 aggregating to approximately $8.9 million (the “Impacted March Tests”).

On May 18, 2023, the Company submitted a letter to Noridian explaining, among other things, (i) the Company’s belief that the Billing Articles impose new restrictions on Medicare coverage for the CareDx tests from those contained in the existing LCDs, (ii) that the Company planned to submit claims for reimbursement for the Impacted March Tests for which the Company has not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing Articles, and (iii) that AlloSure Kidney orders with a date of service on or after March 31, 2023 for other indications outside the parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article. Following the submission of this letter to Noridian on May 18, 2023, the Company submitted claims for reimbursement for the Impacted March Tests for which the Company subsequently received payment from Noridian and recognized revenue totaling approximately $7.8 million in the second quarter of 2023.

The Company has certain unbilled AlloSure Kidney claims with a service date after March 31, 2023, where the reason for testing is not specified by the ordering physician. The Company is in the process of supplementation for these tests. If these AlloSure Kidney tests are within the parameters of the Revised Billing Article, the Company will bill and would expect to recognize revenue in the quarter that the supplementation is completed.

CareDx continued the Medicare reimbursement submissions for AlloMap Heart or AlloSure Heart following the issuance of the Billing Articles. In addition, CareDx informed Noridian on May 18, 2023 that until Noridian adopted the Revised Billing Article, CareDx would continue to submit AlloSure Heart tests for reimbursement only when used in conjunction with AlloMap Heart according to requirements of the Billing Article currently effective at Noridian. The Company also informed Noridian on May 18, 2023 that (i) until June 30, 2023, it planned to submit claims for reimbursement for AlloMap Heart and AlloSure Heart tests for which the Company has not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing Articles, and (ii) AlloSure Heart and AlloMap Heart orders placed on or after June 30, 2023 for other indications outside the surveillance and for-cause parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article.

On August 28, 2023, the Company submitted a subsequent letter to Noridian regarding its AlloSure Heart and AlloMap Heart testing submissions, explaining, among other things, that (i) prior to August 17, 2023, the Company submitted claims as outlined in its prior communications, including submitting AlloSure Heart and AlloMap Heart claims that were in compliance with the billing article in effect for Noridian (but that were not necessarily in compliance with the Revised Billing Article that had not yet been adopted by Noridian); (ii) for claims with dates of service of August 17, 2023 or later, the Company is submitting AlloSure Heart and AlloMap Heart testing claims in compliance with the Revised Billing Article, including submitting AlloSure Heart claims when not used in conjunction with AlloMap Heart, and submitting HeartCare (AlloSure Heart and AlloMap Heart used together in a single patient encounter) claims for surveillance testing in lieu of a biopsy from 55 days to 370 days post-transplant; and (iii) for AlloSure Heart and AlloMap Heart tests performed on or after August 17, 2023 that are outside the parameters of the Revised Billing Article, certain billing codes will be used to enable any additional review deemed appropriate by Noridian and potential appeal by the Company of the denied claims.

On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto; DL38629, Noridian) that, if adopted, would revise the existing foundational LCD, MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629). On August 14, 2023, MolDX released a draft billing article (DA58019) to accompany the proposed draft LCD, which generally reflected the changes in coverage included in the Revised Billing Article. The comment period end date for this proposed LCD was September 23, 2023. The Company presented at public meetings regarding the proposed draft LCD held on September 18, 2023 and September 20, 2023, with MolDX and Noridian, respectively. The Company also submitted written comments on the proposed draft LCD.

AlloSure Kidney has received positive coverage decisions from several commercial payers, and is reimbursed by other private payers on a case-by-case basis. AlloMap Heart has also received positive coverage decisions for reimbursement from many of the largest U.S. private payers.

In May 2021 and March 2023, the Company purchased a minority investment of common stock in the biotechnology company Miromatrix Medical, Inc. (“Miromatrix”), for an aggregate amount of $5.1 million, and the investment is marked to market. Miromatrix works to eliminate the need for an organ transplant waiting list through the development of implantable engineered biological organs.

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Clinical Studies

In January 2018, the Company initiated the Kidney Allograft Outcomes AlloSure Kidney Registry study (“K-OAR”) to develop additional data on the clinical utility of AlloSure Kidney for surveillance of kidney transplant recipients. K-OAR is a multicenter, non-blinded, prospective observational cohort study which has enrolled more than 1,700 renal transplant patients who will receive AlloSure Kidney long-term surveillance.

In September 2018, the Company initiated the Surveillance HeartCare™ Outcomes Registry (“SHORE”). SHORE is a prospective, multi-center, observational registry of patients receiving HeartCare for surveillance. HeartCare combines the gene expression profiling technology of AlloMap Heart with the dd-cfDNA analysis of AlloSure® Heart in one surveillance solution.

In September 2019, the Company announced the commencement of the Outcomes of KidneyCare on Renal Allografts (“OKRA”) study, which is an extension of K-OAR. OKRA is a prospective, multi-center, observational, registry of patients receiving KidneyCare for surveillance. KidneyCare combines the dd-cfDNA analysis of AlloSure Kidney with the gene expression profiling technology of AlloMap Kidney and the predictive artificial intelligence technology of iBox for a multimodality surveillance solution. The Company has not yet made any applications to private payers for reimbursement coverage of AlloMap Kidney or KidneyCare.

Products

The Company’s suite of AlloSeq products are commercial next generation sequencing (“NGS”)-based kitted solutions. These products include: AlloSeq™ Tx, a high-resolution Human Leukocyte Antigen (“HLA”) typing solution, AlloSeq™ cfDNA, a surveillance solution designed to measure dd-cfDNA in blood to detect active rejection in transplant recipients, and AlloSeq™ HCT, a solution for chimerism testing for stem cell transplant recipients.

The Company’s other HLA typing products include: Olerup SSP®, based on the sequence specific primer (“SSP”) technology; and QTYPE®, which uses real-time polymerase chain reaction (“PCR”) methodology, to perform HLA typing.

In March 2021, the Company acquired certain assets of BFS Molecular S.R.L. (“BFS Molecular”), a software company focused on NGS-based patient testing solutions. BFS Molecular brings extensive software and algorithm development capabilities for NGS transplant surveillance products.

Patient and Digital Solutions

Following the acquisitions of both Ottr and XynManagement, the Company is a leading provider of transplant patient management software (“Ottr software”), as well as of transplant quality tracking and waitlist management solutions. Ottr software provides comprehensive solutions for transplant patient management and enables integration with electronic medical record (“EMR”) systems providing patient surveillance management tools and outcomes data to transplant centers. XynManagement provides two unique solutions, XynQAPI software (“XynQAPI”) and XynCare. XynQAPI simplifies transplant quality tracking and Scientific Registry of Transplant Recipients reporting. XynCare includes a team of transplant assistants who maintain regular contact with patients on the waitlist to help prepare for their transplant and maintain eligibility.

In September 2020, the Company launched AlloCare, a mobile app that provides a patient-centric resource for transplant recipients to manage medication adherence, coordinate with Patient Care Managers for AlloSure scheduling and measure health metrics.

In January 2021, the Company acquired TransChart. TransChart provides EMR software to hospitals throughout the U.S. to care for patients who have or may need an organ transplant. As part of the Company’s acquisition of TransChart in January 2021, the Company acquired TxAccess, a cloud-based service that allows nephrologists and dialysis centers to electronically submit referrals to transplant programs and closely follow and assist patients through the transplant waitlist process and, ultimately, through transplantation.

In June 2021, the Company acquired the Transplant Hero patient application. The application helps patients manage their medications through alarms and interactive logging of medication events.

Also in June 2021, the Company entered into a strategic agreement with OrganX, which was amended in April 2022, to develop clinical decision support tools across the transplant patient journey. Together, the Company and OrganX will develop advanced analytics that integrate AlloSure, the first transplant-specific dd-cfDNA assay, with large transplant databases to provide clinical data solutions. This partnership delivers the next level of innovation beyond multi-modality by incorporating a variety of clinical inputs to create a universal composite scoring system. The Company has agreed to potential future milestone payments.

In November 2021, the Company acquired MedActionPlan, a New Jersey-based provider of medication safety, medication adherence and patient education. MedActionPlan is a leader in patient medication management for transplant patients and beyond.

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In December 2021, the Company acquired TTP, a transplant-focused pharmacy located in Mississippi. TTP provides individualized transplant pharmacy services for patients at multiple transplant centers located throughout the U.S.

In January 2023, the Company acquired HLA Data Systems, a Texas-based company that provides software and interoperability solutions for the histocompatibility and immunogenetics community. HLA Data Systems is a leader in the laboratory information management industry for human leukocyte antigen laboratories.

In July 2023, the Company acquired MediGO, an organ transplant supply chain and logistics company. MediGO provides access to donated organs by digitally transforming donation and transplantation workflows to increase organ utilization.

Liquidity and Capital Resources

The Company has incurred significant losses and negative cash flows from operations since its inception and had an accumulated deficit of $534.2 million at September 30, 2023. As of September 30, 2023, the Company had cash, cash equivalents and marketable securities of $268.2 million and no debt outstanding.

Shelf Registration Statement

On May 10, 2023, the Company filed a universal shelf registration statement (File No. 333-271814) (the “Registration Statement”), whereby the Company can sell from time to time shares of its common stock, preferred stock, debt securities, warrants, units or rights comprised of any combination of these securities, for the Company’s own account in one or more offerings under the Registration Statement. The terms of any offering under the Registration Statement will be established at the time of such offering and will be described in a prospectus supplement to the Registration Statement filed with the Securities and Exchange Commission (the “SEC”) prior to the completion of any such offering.

Stock Repurchase Program

On December 3, 2022, the Company’s Board of Directors approved a stock repurchase program (the “Repurchase Program”), whereby the Company may purchase up to $50 million of shares of its common stock over a period of up to two years, commencing on December 8, 2022. The Repurchase Program may be carried out at the discretion of a committee of the Company’s Board of Directors through open market purchases, one or more Rule 10b5-1 trading plans and block trades and in privately negotiated transactions. During the three and nine months ended September 30, 2023, the Company purchased an aggregate of 92,766 shares and 164,238 shares of its common stock, respectively, under the Repurchase Program for an aggregate purchase price of $0.8 million and $1.6 million, respectively. As of September 30, 2023, $47.7 million remained available for future share repurchase under the Repurchase Program.

The significant accounting policies and estimates used in preparation of the unaudited condensed consolidated financial statements are described in the Company’s audited consolidated financial statements as of and for the year ended December 31, 2022, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 27, 2023. Material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 are reflected below.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”), and follow the requirements of the SEC for interim reporting. As permitted under those rules, certain notes and other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of the Company’s financial information. The condensed consolidated balance sheet as of December 31, 2022 has been derived from audited consolidated financial statements as of that date but does not include all of the financial information required by U.S. GAAP for complete financial statements. Operating results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023.

Use of Estimates

The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the unaudited condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to transaction price

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estimates used for testing services revenue; standalone fair value of patient and digital solutions revenue performance obligations; accrued expenses for clinical studies; inventory valuation; the fair value of issued common stock warrants and embedded derivatives; the fair value of assets and liabilities acquired in a business combination or an assets acquisition (including identifiable intangible assets acquired); the fair value of contingent consideration recorded in connection with a business combination or an asset acquisition; the grant date fair value assumptions used to estimate stock-based compensation expense; income taxes; impairment of long-lived assets and indefinite-lived assets (including goodwill); and legal contingencies. Actual results could differ from those estimates.

Concentrations of Credit Risk and Other Risks and Uncertainties

For the three months ended September 30, 2023 and 2022, approximately 36% and 53%, respectively, of total revenue was derived from Medicare. For the nine months ended September 30, 2023 and 2022, approximately 41% and 54%, respectively, of total revenue was derived from Medicare.

As of September 30, 2023 and December 31, 2022, approximately 36% and 27%, respectively, of accounts receivable was due from Medicare. No other payer or customer represented more than 10% of accounts receivable at either September 30, 2023 or December 31, 2022.

Marketable Securities

The Company considers all highly liquid investments in securities with a maturity of greater than three months at the time of purchase to be marketable securities. As of September 30, 2023, the Company’s short-term marketable securities consisted of corporate debt securities with maturities of greater than three months but less than twelve months at the time of purchase, which were classified as current assets on the condensed consolidated balance sheet.

The Company classifies its short-term marketable securities as held-to-maturity at the time of purchase and reevaluates such designation at each balance sheet date. The Company has the positive intent and ability to hold these marketable securities to maturity. Short-term marketable securities are carried at amortized cost and are adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income (expense), net on the condensed consolidated statements of operations. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on short-term marketable securities are included in interest income (expense), net. The cost of securities sold will be determined using specific identification.

The Company considers investments in securities with remaining maturities of over one year as long-term investments. As of September 30, 2023, the Company’s long-term marketable securities consisted of corporate equity securities and corporate debt securities. These long-term marketable securities are classified as other assets on the condensed consolidated balance sheet.

The Company classifies its long-term marketable debt securities as available-for-sale and reevaluates such designation at each balance sheet date. Unrealized gains and losses from the reevaluation of the long-term marketable debt securities, if any, are included in other comprehensive gain (loss) in the condensed consolidated statement of comprehensive income (loss). Realized gains and losses and declines in value judged to be other-than-temporary, if any, on long-term marketable securities are included in interest income (expense), net.

The Company records its long-term marketable equity securities at fair market value. Unrealized gains and losses from the remeasurement of the long-term marketable equity securities to fair value are included in other income (expense), net, in the condensed consolidated statements of operations.

Leases

The Company adopted Accounting Standard Codification (“ASC”) Topic 842, Leases, and determines if an arrangement is or contains a lease at contract inception. A right-of-use (“ROU”) asset, representing the underlying asset during the lease term, and a lease liability, representing the payment obligation arising from the lease, are recognized on the condensed consolidated balance sheet at lease commencement based on the present value of the payment obligation. For operating leases, expense is recognized on a straight-line basis over the lease term. For finance leases, interest expense on the lease liability is recognized using the effective interest method and amortization of the ROU asset is recognized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. The Company also has lease arrangements with lease and non-lease components. The Company elected the practical expedient not to separate non-lease components from lease components for the Company’s facility leases. The Company also elected to apply the short-term lease measurement and recognition exemption in which ROU assets and lease liabilities are not recognized for leases with an initial term of 12 months or less.

The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment.

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As of September 30, 2023, the Company’s leases had remaining terms of 0.17 years to 9.35 years, some of which include options to extend the lease term.

Revenue

The Company recognizes revenue from testing services, product sales and patient and digital solutions revenue in the amount that reflects the consideration that it expects to be entitled in exchange for goods or services as it transfers control to its customers. Revenue is recorded considering a five-step revenue recognition model that includes identifying the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price to the performance obligations and recognizing revenue when, or as, an entity satisfies a performance obligation.

Testing Services Revenue

AlloSure Kidney, AlloMap Heart, AlloSure Heart and AlloSure Lung patient tests are ordered by healthcare providers. The Company receives a test requisition form with payer information along with a collected patient blood sample. The Company considers the patient to be its customer and the test requisition form to be the contract. Testing services are performed in the Company’s laboratory. Testing services represent one performance obligation in a contract and are performed when results of the test are provided to the healthcare provider, at a point in time.

The healthcare providers that order the tests and on whose behalf the Company provides testing services are generally not responsible for the payment of these services. The first and second revenue recognition criteria are satisfied when the Company receives a test requisition form with payer information from the healthcare provider. Generally, the Company bills third-party payers upon delivery of an AlloSure Kidney, AlloMap Heart, AlloSure Heart or AlloSure Lung test result to the healthcare provider. Amounts received may vary amongst payers based on coverage practices and policies of the payer. The Company has used the portfolio approach under ASC Topic 606, Revenue from Contracts with Customers, to identify financial classes of payers. Revenue recognized for Medicare and other contracted payers is based on the agreed current reimbursement rate per test, adjusted for historical collection trends where applicable. The Company estimates revenue for non-contracted payers and self-payers using transaction prices determined for each financial class of payers using history of reimbursements. This includes analysis of an average reimbursement per test and a percentage of tests reimbursed. This estimate requires significant judgment.

The Company monitors revenue estimates at each reporting period based on actual cash collections in order to assess whether a revision to the estimate is required. Changes in transaction price estimates are updated quarterly based on actual cash collected or changes made to contracted rates.

On March 2, 2023, MolDX issued a new Billing Article, with an effective date of March 31, 2023. The Billing Article impacts Medicare coverage for AlloSure Kidney, AlloSure Heart and AlloMap Heart and requires the Company to implement new processes to address requirements related to Medicare claim submissions. ASC 606-10-25-1 requires the Company to assess whether it is probable that it will collect substantially all of the consideration to which it will be entitled when determining if a contract with a customer exists. Based upon the Company’s review of the Billing Article, it was determined to pause Medicare reimbursement submissions for AlloSure Kidney commencing on March 7, 2023 that created uncertainty around the collection of the claims. Accordingly, the Company did not submit claims for approximately 3,200 AlloSure Kidney tests for Medicare reimbursement for the period from March 7, 2023 through March 31, 2023 and did not recognize revenue on these claims in the first quarter of 2023 aggregating to approximately $8.9 million.

On May 18, 2023, the Company submitted a letter to Noridian explaining, among other things, (i) the Company’s belief that the Billing Articles imposed new restrictions on Medicare coverage for the CareDx tests from those contained in the existing LCDs, (ii) that the Company planned to submit claims for reimbursement for the Impacted March Tests for which the Company has not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing Articles, and (iii) that AlloSure Kidney orders with a date of service on or after March 31, 2023 for other indications outside the parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article. Following the submission of this letter to Noridian, on May 18, 2023, the Company submitted claims for reimbursement for the Impacted March Tests, for which the Company subsequently received payment from Noridian and recognized revenue totaling approximately $7.8 million in the second quarter of 2023.

The Company has certain unbilled AlloSure Kidney claims with a service date after March 31, 2023, where the reason for testing is not specified by the ordering physician. The Company is in the process of supplementation for these tests. If these AlloSure Kidney tests are within the parameters of the Revised Billing Article, the Company will bill and would expect to recognize revenue in the quarter that the supplementation is completed.

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The Company continues its Medicare reimbursement submissions for AlloMap Heart or AlloSure Heart following the issuance of the Billing Articles. In addition, the Company informed Noridian on May 18, 2023 that until Noridian adopted the Revised Billing Article, the Company would continue to submit AlloSure Heart tests for reimbursement only when used in conjunction with AlloMap Heart. The Company also informed Noridian on May 18, 2023 that (i) until June 30, 2023, it planned to submit claims for reimbursement for AlloMap Heart and AlloSure Heart tests for which the Company has not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing Articles, and (ii) AlloSure Heart and AlloMap Heart orders placed on or after June 30, 2023 for other indications outside the surveillance and for-cause parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article.

On August 28, 2023, the Company submitted a subsequent letter to Noridian regarding its AlloSure Heart and AlloMap Heart testing submissions, explaining, among other things, that (i) prior to August 17, 2023, the Company submitted claims as outlined in its prior communications, including submitting AlloSure Heart and AlloMap Heart claims that were in compliance with the billing article in effect for Noridian (but that were not necessarily in compliance with the Revised Billing Article that had not yet been adopted by Noridian); (ii) for claims with dates of service of August 17, 2023 or later, the Company is submitting AlloSure Heart and AlloMap Heart testing claims in compliance with the Revised Billing Article, including submitting AlloSure Heart claims when not used in conjunction with AlloMap Heart, and submitting HeartCare (AlloSure Heart and AlloMap Heart used together in a single patient encounter) claims for surveillance testing in lieu of a biopsy from 55 days to 370 days post-transplant; and (iii) for AlloSure Heart and AlloMap Heart tests performed on or after August 17, 2023 that are outside the parameters of the Revised Billing Article, certain billing codes will be used to enable any additional review deemed appropriate by Noridian and potential appeal by the Company of the denied claims.

On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto; DL38629, Noridian) that, if adopted, would revise the existing foundational LCD, MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629). On August 14, 2023, MolDX released a draft billing article (DA58019) to accompany the proposed draft LCD, which generally reflected the changes in coverage included in the Revised Billing Article. The comment period end date for this proposed LCD was September 23, 2023. The Company presented at public meetings regarding the proposed draft LCD held on September 18, 2023 and September 20, 2023, with MolDX and Noridian, respectively. The Company also submitted written comments on the proposed draft LCD.

Product Revenue

Product revenue is recognized from the sale of products to end-users, distributors and strategic partners when all revenue recognition criteria are satisfied. The Company generally has a contract or a purchase order from a customer with the specified required terms of order, including the number of products ordered. Transaction prices are determinable and products are delivered and the risk of loss is passed to the customer upon either shipping or delivery, as per the terms of the agreement.

Patient and Digital Solutions Revenue

Patient and digital solutions revenue is mainly derived from a combination of software as a service (“SaaS”) and perpetual software license agreements entered into with various transplant centers, which are the Company’s customers for this class of revenue. The main performance obligations in connection with the Company’s SaaS and perpetual software license agreements are the following: (i) implementation services and delivery of the perpetual software license, which are considered a single performance obligation, and (ii) post contract support. The Company allocates the transaction price to each performance obligation based on relative stand-alone selling prices of each distinct performance obligation. Digital revenue in connection with perpetual software license agreements is recognized over time based on the Company’s satisfaction of each distinct performance obligation in each agreement.

Perpetual software license agreements typically require advance payments from customers upon the achievement of certain milestones. The Company records deferred revenue in relation to these agreements when cash payments are received or invoices are issued in advance of the Company’s performance, and generally recognizes revenue over the contractual term, as performance obligations are fulfilled.

In addition, the Company derives patient and digital solutions revenue from software subscriptions and medication sales. The Company generally bills software subscription fees in advance. Revenue from software subscriptions is deferred and recognized ratably over the subscription term. The medication sales revenue is recognized based on the negotiated contract price with the governmental, commercial and non-commercial payers with any applicable patient co-pay. The Company recognizes revenue from medication sales when prescriptions are delivered.

Recent Accounting Pronouncements

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Basic and diluted net loss per share have been computed by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common share equivalents as their effect would have been antidilutive.

The following tables set forth the computation of the Company’s basic and diluted net loss per share (in thousands, except shares and per share data):

			Three Months Ended September 30,												Nine Months Ended September 30,
			2023						2022						2023						2022
Numerator:
Net loss used to compute basic and diluted net loss per share			$	(23,485)					$	(16,939)					$	(72,187)					$	(58,284)
Denominator:
Weighted-average shares used to compute basic and diluted net loss per share			54,178,759						53,489,418						53,891,374						53,253,210
Net loss per share:
Basic and diluted			$	(0.43)					$	(0.32)					$	(1.34)					$	(1.09)

The following potentially dilutive securities have been excluded from diluted net loss per share as of September 30, 2023 and 2022 because their effect would be antidilutive:

			Three and Nine Months Ended September 30,
			2023						2022
Shares of common stock subject to outstanding options			3,167,977						3,116,421
Shares of common stock subject to outstanding common stock warrants			—						3,132
Restricted stock units			4,977,616						3,077,633
Total common stock equivalents			8,145,593						6,197,186

The Company records its financial assets and liabilities at fair value. The carrying amounts of certain financial instruments of the Company, including cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:

•Level 1: Inputs that include quoted prices in active markets for identical assets and liabilities.

•Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

•Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

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The following tables set forth the Company’s financial assets and liabilities, measured at fair value on a recurring basis, as of September 30, 2023 and December 31, 2022 (in thousands):

			September 30, 2023
			Fair Value Measured Using
			(Level 1)						(Level 2)						(Level 3)						Total Balance
Assets
Cash equivalents:
Money market funds			$	54,405					$	—					$	—					$	54,405
Long-term marketable securities:
Corporate equity securities			992						—						—						992
Total			$	55,397					$	—					$	—					$	55,397
Liabilities
Short-term liabilities:
Contingent consideration			$	—					$	—					$	2,083					$	2,083
Long-term liabilities:
Contingent consideration			—						—						4,735						4,735
Total			$	—					$	—					$	6,818					$	6,818

			December 31, 2022
			Fair Value Measured Using
			(Level 1)						(Level 2)						(Level 3)						Total Balance
Assets
Cash equivalents:
Money market funds			$	66,594					$	—					$	—					$	66,594
Long-term marketable securities:
Corporate equity securities			2,076						—						—						2,076
Total			$	68,670					$	—					$	—					$	68,670
Liabilities
Short-term liabilities:
Contingent consideration			$	—					$	—					$	1,025					$	1,025
Long-term liabilities:
Contingent consideration			—						—						2,418						2,418
Common stock warrant liability			—						—						32						32
Total			$	—					$	—					$	3,475					$	3,475

The following table presents the issuances, exercises, changes in fair value and reclassifications of the Company’s Level 3 financial instruments that are measured at fair value on a recurring basis (in thousands):

			(Level 3)
Common Stock Warrant Liability and Contingent Consideration
Balance as of December 31, 2022			$	3,475
Exercise of warrants			(22)
Change in estimated fair value of common stock warrant liability			(10)
Change in estimated fair value of contingent consideration			1,731
Addition of estimated fair value of contingent consideration			2,269
Payments related to contingent consideration			(625)
Balance as of September 30, 2023			$	6,818

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During March 2023, the Company wrote off $1.0 million of its investment in convertible preferred shares of Cibiltech SAS (“Cibiltech”), which was carried at cost. Cibiltech’s operations have been liquidated. The fair value of this investment was based on Level 3 inputs.

In July 2023, the Company entered into a Securities Holders’ Agreement (the “Agreement”) with a private entity based in France. The private entity was established to continue Cibiltech's activity, which consists of designing, developing, publishing, promoting, distributing, and marketing of software related to predictive solutions, to monitoring and/or to remote monitoring in the field of human organ allotrasplantation, allografting, and chronic organ diseases. The private entity retained all assets of Cibiltech, including its licenses. Pursuant to the Agreement, the Company agreed to invest a certain amount in the private entity, in order to continue the commercialization of the iBox technology. The Company's investment is in the form of ordinary and Class B shares carried at cost. This investment is not considered material to the Company's condensed consolidated financial statements.    

In determining fair value, the Company uses various valuation approaches within the fair value measurement framework. The valuation methodologies used for the Company’s instruments measured at fair value and their classification in the valuation hierarchy are summarized below:

•Money market funds – Investments in money market funds are classified within Level 1. Money market funds are valued at the closing price reported by the fund sponsor from an actively traded exchange. At September 30, 2023 and December 31, 2022, money market funds were included as cash and cash equivalents in the condensed consolidated balance sheets.

•Long-term marketable equity and debt securities – Investments in long-term marketable equity securities are classified within Level 1. The securities are recorded at fair value based on readily available quoted market prices in active markets. Investments in long-term marketable debt securities are classified within Level 2. The securities are recorded at fair value based on observable inputs for quoted prices for identical or similar assets in markets that are not active. Long-term marketable securities are located within other assets on the condensed consolidated balance sheets.

•Contingent consideration – Contingent consideration is classified within Level 3. Contingent consideration relates to asset acquisitions and business combinations. The Company recorded the estimate of the fair value of the contingent consideration based on its evaluation of the probability of the achievement of the contractual conditions that would result in the payment of the contingent consideration. Contingent consideration was estimated using the fair value of the milestones to be paid if the contingency is met based on management’s estimate of the probability of success and projected revenues for revenue-based considerations at discounted rates ranging from 7% to 12% at September 30, 2023 and 12% at December 31, 2022. The significant input in the Level 3 measurement that is not supported by market activity is the Company’s probability assessment of the achievement of the milestones. The value of the liability is subsequently remeasured to fair value at each reporting date, and the change in estimated fair value is recorded as income or expense within operating expenses in the consolidated statements of operations until the milestones are paid, expire or are no longer achievable. Increases or decreases in the estimation of the probability percentage result in a directionally similar impact to the fair value measurement of the contingent consideration liability. The carrying amount of the contingent consideration liability represents its fair value.

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Cash, Cash Equivalents and Restricted Cash

A reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the amount reported within the condensed consolidated statements of cash flows is shown in the table below (in thousands):

			September 30, 2023						September 30, 2022
Cash and cash equivalents			$	75,980					$	82,959
Restricted cash			582						198
Total cash, cash equivalents and restricted cash at the end of the period			$	76,562					$	83,157

Marketable Securities

All short-term marketable securities were considered held-to-maturity at September 30, 2023. At September 30, 2023, some of the Company’s short-term marketable securities were in an unrealized loss position. The Company determined that it had the positive intent and ability to hold until maturity all short-term marketable securities that have been in a continuous loss position, thus there was no recognition of any other-than-temporary impairment as of September 30, 2023. All short-term marketable securities with unrealized losses as of the balance sheet date have been in a loss position for less than twelve months. Contractual maturities of the short-term marketable securities were within one year or less.

The long-term marketable equity securities were recorded at fair market value with changes in the fair value recognized in earnings at September 30, 2023 and December 31, 2022. The long-term marketable debt securities were considered available-for-sale at September 30, 2023 and December 31, 2022. The contractual maturities of the long-term marketable debt securities are between one and three years.

The amortized cost, gross unrealized holding gains (losses) and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands):

			September 30, 2023
			Amortized Cost						Unrealized Holding Gains (Losses)						Fair Value
Short-term marketable securities:
U.S. agency securities			$	100,306					$	1,991					$	102,297
Corporate debt securities			91,898						584						92,482
Total short-term marketable securities			192,204						2,575						194,779
Long-term marketable securities:
Corporate equity securities			5,100						(4,108)						992
Total long-term marketable securities			5,100						(4,108)						992
Total			$	197,304					$	(1,533)					$	195,771

			December 31, 2022
			Amortized Cost						Unrealized Holding Gains (Losses)						Fair Value
Short-term marketable securities:
U.S. agency securities			$	79,347					$	452					$	79,799
Corporate debt securities			123,821						(220)						123,601
Total short-term marketable securities			203,168						232						203,400
Long-term marketable securities:
Corporate equity securities			5,000						(2,924)						2,076
Total long-term marketable securities			5,000						(2,924)						2,076
Total			$	208,168					$	(2,692)					$	205,476

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Business Combinations

HLA Data Systems

In January 2023, the Company acquired HLA Data Systems, a Texas-based company that provides software and interoperability solutions for the histocompatibility and immunogenetics community. The Company acquired HLA Data Systems with a combination of cash consideration paid upfront and contingent consideration with a fair value of $1.3 million.

The Company accounted for the transaction as a business combination using the acquisition method of accounting. Acquisition-related costs of $0.4 million associated with the acquisition were expensed as incurred, and classified as part of general and administrative expenses in the condensed consolidated statement of operations.

Goodwill of $2.1 million arising from the acquisition primarily consists of synergies from integrating HLA Data Systems’ technology with the current testing and digital solutions offered by the Company. The acquisition of HLA Data Systems will provide a robust and comprehensive Laboratory Information Management System and support the laboratory workflows. None of the goodwill is expected to be deductible for income tax purposes. All of the goodwill has been assigned to the Company’s existing operating segment.

The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands):

			Estimated Fair Value						Estimated Useful Lives (Years)
Customer relationships			$	3,010					13
Developed technology			770						11
Trademarks			320						17
Total			$	4,100

Customer relationships acquired by the Company represent the fair value of future projected revenue that is expected to be derived from sales of HLA Data Systems’ products to existing customers. The customer relationships’ fair value has been estimated utilizing a multi-period excess earnings method under the income approach, which reflects the present value of the projected cash flows that are expected to be generated by the customer relationships, less charges representing the contribution of other assets to those cash flows that use projected cash flows with and without the intangible asset in place. The economic useful life was determined based on the distribution of the present value of the cash flows attributable to the intangible asset.

The acquired developed technology represents the fair value of HLA Data Systems’ proprietary software. The trademark acquired consists primarily of the HLA Data Systems brand and markings. The fair value of both the developed technology and the trademark were determined using the relief-from-royalty method under the income approach. This method considers the value of the asset to be the value of the royalty payments from which the Company is relieved due to its ownership of the asset. The royalty rates of 10% and 2% were used to estimate the fair value of the developed technology and the trademark, respectively.

A discount rate of 24% was utilized in estimating the fair value of these three intangible assets.

The pro forma impact of the HLA Data Systems acquisition is not material, and the results of operations of the acquisition have been included in the Company’s condensed consolidated statements of operations from the respective acquisition date.

MediGO

In July 2023, the Company acquired MediGO, an organ transplant supply chain and logistics company. MediGO provides access to donated organs by digitally transforming donation and transplantation workflows to increase organ utilization. The Company acquired MediGO with a combination of cash consideration paid upfront and contingent consideration with a fair value of $0.3 million.

The Company accounted for the transaction as a business combination using the acquisition method of accounting. Acquisition-related costs of $0.3 million associated with the acquisition were expensed as incurred, and classified as part of general and administrative expenses in the condensed consolidated statement of operations.

Goodwill of $0.6 million arising from the acquisition primarily consists of synergies from integrating MediGO’s technology with the current testing and digital solutions offered by the Company. The acquisition of MediGO will provide a comprehensive software platform that optimizes complex logistics from referral to recovery and during the critical movement of organs and teams and gives organ procurement organizations and transplant centers the ability to unify decentralized stakeholders, coordinate resources and make vital decisions with the goal of increasing organ utilization and improving equity and access to

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transplantation. None of the goodwill is expected to be deductible for income tax purposes. All of the goodwill has been assigned to the Company’s existing operating segment.

The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands):

			Estimated Fair Value						Estimated Useful Lives (Years)
Customer relationships			$	810					17
Developed technology			850						12
Trademarks			360						17
Total			$	2,020

Customer relationships acquired by the Company represent the fair value of future projected revenue that is expected to be derived from sales of MediGO’s products to existing customers. The customer relationships’ fair value has been estimated utilizing a multi-period excess earnings method under the income approach, which reflects the present value of the projected cash flows that are expected to be generated by the customer relationships, less charges representing the contribution of other assets to those cash flows that use projected cash flows with and without the intangible asset in place. The economic useful life was determined based on the distribution of the present value of the cash flows attributable to the intangible asset.

The acquired developed technology represents the fair value of MediGO’s proprietary software. The trademark acquired consists primarily of the MediGO brand and markings. The fair value of both the developed technology and the trademark were determined using the relief-from-royalty method under the income approach. This method considers the value of the asset to be the value of the royalty payments from which the Company is relieved due to its ownership of the asset. The royalty rates of 10% and 2% were used to estimate the fair value of the developed technology and the trademark, respectively.

A discount rate of 25% was utilized in estimating the fair value of these three intangible assets.

The pro forma impact of the MediGO acquisition is not material, and the results of operations of the acquisition have been included in the Company’s condensed consolidated statements of operations from the respective acquisition date.

Combined Consideration Paid

The following table summarizes the consideration paid for HLA Data Systems and MediGO and the provisional amounts of the assets acquired and liabilities assumed recognized at their estimated fair value at the acquisition date (in thousands):

			Total
Consideration
Cash			$	6,682
Total consideration			$	6,682
Recognized amounts of identifiable assets acquired and liabilities assumed
Current assets			$	1,413
Identifiable intangible assets			6,120
Current liabilities			(1,060)
Other current liabilities			(810)
Contingent considerations			(1,620)
Other liabilities			(7)
Total identifiable net assets acquired			4,036
Goodwill			2,646
Total consideration			$	6,682

The preliminary allocation of the purchase price to assets acquired and liabilities assumed was based on the fair value of such assets and liabilities as of the acquisition date.

Asset Acquisition

Effective as of August 9, 2023, the Company purchased an asset from a private entity. The asset consists of a licensing agreement with a university institution. See also Note 9.

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Goodwill

Goodwill is recorded when the purchase price of an acquisition exceeds the fair value of the net tangible and identified intangible assets acquired.

Goodwill is tested annually for impairment at the reporting unit level during the fourth quarter or upon the occurrence of certain events or substantive changes in circumstances. The Company identified an indicator of goodwill impairment in the three and nine months ended September 30, 2023. The balance of the Company’s goodwill was $40.2 million as of September 30, 2023 and $37.5 million as of December 31, 2022.

Goodwill Impairment

The Company assessed the current and future economic outlook as of September 30, 2023 for its single reporting unit and the Company experienced a sustained decrease in its share price, an indicator for impairment of goodwill. The evaluation began with a qualitative assessment to determine if it was more likely than not that the fair value of the reporting unit was less than its carrying value. The qualitative assessment did not indicate that it was more likely than not that the fair value exceeded the carrying value, which led to a quantitative assessment.

The Company estimated the fair value of its reporting unit using a combination of the income and market approaches. In performing the goodwill impairment test, the Company used an exit multiple given the development phase of the Company and a discount rate of 16.4% in its estimation of fair value. The evaluation performed resulted in no impairment as of September 30, 2023.

Intangible Assets

The following table presents details of the Company’s intangible assets as of September 30, 2023 ($ in thousands):

			September 30, 2023
			Gross Carrying Amount						Accumulated Amortization						Foreign Currency Translation						Net Carrying Amount						Weighted Average Remaining Useful Life (In Years)
Intangible assets with finite lives:
Acquired and developed technology			$	37,367					$	(17,529)					$	(2,560)					$	17,278					7.4
Customer relationships			25,718						(8,663)						(2,334)						14,721						9.5
Commercialization rights			11,578						(4,180)						—						7,398						5.8
Trademarks and tradenames			5,220						(1,617)						(356)						3,247						9.6
Total intangible assets with finite lives			79,883						(31,989)						(5,250)						42,644
Intangible assets with indefinite lives:
Acquired in-process technology			1,250						—						—						1,250
Favorable license agreement			2,561						—						—						2,561
Total intangible assets with indefinite lives			3,811						—						—						3,811
Total intangible assets			$	83,694					$	(31,989)					$	(5,250)					$	46,455

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The following table presents details of the Company’s intangible assets as of December 31, 2022 ($ in thousands):

			December 31, 2022
			Gross Carrying Amount						Accumulated Amortization						Foreign Currency Translation						Net Carrying Amount						Weighted Average Remaining Useful Life (In Years)
Intangible assets with finite lives:
Acquired and developed technology			$	35,747					$	(15,138)					$	(2,369)					$	18,240					7.5
Customer relationships			21,898						(7,459)						(2,104)						12,335						9.0
Commercialization rights			11,579						(3,233)						—						8,346						6.6
Trademarks and tradenames			4,540						(1,345)						(315)						2,880						8.5
Total intangible assets with finite lives			73,764						(27,175)						(4,788)						41,801
Acquired in-process technology			1,250						—						—						1,250
Total intangible assets			$	75,014					$	(27,175)					$	(4,788)					$	43,051

Acquisition of Intangible Assets

In January 2023 and July 2023, the Company acquired the intangible assets of HLA Data Systems and MediGO, respectively. The intangible assets are included in Acquired and developed technology, Customer relationships and Trademarks and tradenames as of September 30, 2023.

Amortization of Intangible Assets

Intangible assets are carried at cost less accumulated amortization. Amortization expenses are recorded to cost of testing services, cost of product, cost of patient and digital solutions, and sales and marketing expenses in the condensed consolidated statements of operations.

The following table summarizes the Company’s amortization expense of intangible assets (in thousands):

			Three Months Ended September 30,												Nine Months Ended September 30,
			2023						2022						2023						2022
Cost of testing services			$	329					$	329					$	987					$	987
Cost of product			408						415						1,242						1,305
Cost of patient and digital solutions			265						237						768						709
Sales and marketing			616						554						1,817						1,702
Total			$	1,618					$	1,535					$	4,814					$	4,703

The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of September 30, 2023 (in thousands):

Years Ending December 31,						Cost of Testing Services						Cost of Product						Cost of Patient and Digital Solutions						Sales and Marketing						Total
Remainder of 2023						$	329					$	405					$	271					$	634					$	1,639
2024						1,316						1,621						850						2,494						6,281
2025						1,316						1,621						681						2,494						6,112
2026						1,316						732						681						2,492						5,221
2027						1,316						732						681						2,478						5,207
Thereafter						2,825						3,260						2,142						9,957						18,184
Total future amortization expense						$	8,418					$	8,371					$	5,306					$	20,549					$	42,644

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Inventory

Inventory consisted of the following (in thousands):

			September 30, 2023						December 31, 2022
Finished goods			$	3,173					$	2,962
Work in progress			4,939						4,306
Raw materials			9,866						11,964
Total inventory			$	17,978					$	19,232

Accrued and Other Liabilities

Accrued and other liabilities consisted of the following (in thousands):

			September 30, 2023						December 31, 2022
Clinical studies			$	14,677					$	14,816
Professional fees			11,134						6,115
Short-term lease liability			5,958						5,591
Deferred revenue			5,766						5,342
Laboratory processing fees and materials			2,241						2,189
Contingent consideration			2,083						1,025
Accrued royalty			1,793						4,633
Deferred payments for intangible assets			920						2,062
Accrued shipping expenses			370						489
License and other collaboration fees			212						1,000
Capital expenditures			—						1,316
Other accrued expenses			1,884						4,553
Total accrued and other liabilities			$	47,038					$	49,131

Leases

The Company leases its operating and office facilities for various terms under long-term, non-cancelable operating lease agreements in Brisbane, California; Columbus, Ohio; West Chester, Pennsylvania; Flowood, Mississippi; Gaithersburg, Maryland; Fremantle, Australia; and Stockholm, Sweden. 

The Company’s facility leases expire at various dates through 2033. In the normal course of business, it is expected that these leases will be renewed or replaced by leases on other properties.

As of September 30, 2023, the carrying value of the ROU asset was $31.0 million. The related current and non-current liabilities as of September 30, 2023 were $6.0 million and $29.3 million, respectively. The current and non-current lease liabilities are included in accrued and other current liabilities and operating lease liability, less current portion, respectively, in the condensed consolidated balance sheets.

The following table summarizes the lease cost for the three and nine months ended September 30, 2023 and 2022 (in thousands):

			Three Months Ended September 30,												Nine Months Ended September 30,
			2023						2022						2023						2022
Operating lease cost			$	1,981					$	1,955					$	5,936					$	4,740
Total lease cost			$	1,981					$	1,955					$	5,936					$	4,740

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			September 30, 2023						December 31, 2022
Other information:
Weighted-average remaining lease term (in years)			5.63						6.26
Weighted-average discount rate (%)			7.1		%				7.1		%

In February and June 2022, the Company entered into various lease agreements to lease office buildings in California, Nebraska and Australia with lease terms ranging from 2 to 10.5 years. Certain leases have options to renew the respective lease terms ranging from 5 to 10 years.

In June 2022, the Company modified the termination date of the lease agreement for its former headquarters in South San Francisco, California from December 31, 2022 to July 15, 2022. As a result, the Company remeasured its lease liability using the current incremental borrowing rate and made an adjustment by reducing the ROU asset and lease liability by $0.5 million.

Lease liabilities for the lease agreements made in February and June 2022 are recognized at the present value of the fixed lease payments using the current incremental borrowing rate at the lease commencement date. ROU assets are recognized based on the initial present value of the fixed lease payments.

The following table summarizes the ROU assets and lease liabilities for certain lease agreements which commenced in July 2022 (in thousands):

			September 30, 2023						December 31, 2022
ROU assets			$	12,897					$	14,321
Lease liabilities			$	13,915					$	15,302

The following table summarizes the ROU assets and lease liabilities for certain lease agreements which commenced in August 2022 (in thousands):

			September 30, 2023						December 31, 2022
ROU assets			$	5,465					$	5,814
Lease liabilities			$	5,732					$	6,005

Maturities of operating lease liabilities as of September 30, 2023 are as follows (in thousands):

Years Ending December 31,												Operating Leases
Remainder of 2023												$	2,024
2024												7,955
2025												7,706
2026												7,019
2027												7,166
Thereafter												10,604
Total lease payments												42,474
Less imputed interest												7,264
Present value of future minimum lease payments												35,210
Less operating lease liability, current portion												5,958
Operating lease liability, long-term portion												$	29,252

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The following table summarizes the supplemental cash flow information related to leases for the three and nine months ended September 30, 2023 and 2022 (in thousands):

			Three Months Ended September 30,												Nine Months Ended September 30,
			2023						2022						2023						2022
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows used for operating leases			$	1,172					$	822					$	3,871					$	2,746

Royalty Commitments

The Board of Trustees of the Leland Stanford Junior University (“Stanford”)

In June 2014, the Company entered into a license agreement with Stanford (the “Stanford License”), which granted the Company an exclusive license to a patent relating to the diagnosis of rejection in organ transplant recipients using dd-cfDNA. Under the terms of the Stanford License, the Company is required to pay an annual license maintenance fee, six milestone payments and royalties in the low single digits of net sales of products incorporating the licensed technology. In March 2023, the Stanford License agreement was amended, which reduced the maximum royalty rate to a lower rate at which the Company may be liable to Stanford effective from April 2022 and also provided that the Company would seek a review from the U.S. Supreme Court (the “Review”). During the pendency of the Review, certain of the Company’s licensing payment and reporting obligations to Stanford with respect to licensed products sold in the U.S. were suspended. As a result, the Company reversed the excess liability in March 2023.

In May 2023, the Company submitted a petition of certiorari to the U.S. Supreme Court for consideration of the patent infringement suit and in October 2023, the U.S. Supreme Court declined to hear this patent infringement suit. As the Review is complete and our petition for review was denied, the Stanford License automatically terminated, and the Company will be required to pay to Stanford certain past royalties at a reduced rate that were previously suspended within 90 days of the termination.

Illumina

On May 4, 2018, the Company entered into a license agreement with Illumina, Inc. (the “Illumina Agreement”). The Illumina Agreement requires the Company to pay royalties in the mid-single to low double digits on sales of products covered by the Illumina Agreement.

Other Royalty Commitment

Effective as of August 9, 2023, the Company entered into a license agreement with a university institution (the "University Agreement"). The University Agreement requires the Company to pay royalties in the low single digits on sales of products covered by the University Agreement.

Cibiltech Commitments

Pursuant to that certain license and commercialization agreement that the Company entered into with Cibiltech, effective April 30, 2019, the Company will share an agreed-upon percentage of revenue with Cibiltech, if and when revenues are generated from iBox.

In July 2023, the Company entered into a settlement agreement with Cibiltech (the “Settlement Agreement”), pursuant to which the Company agreed to pay a certain amount of its obligation owed to Cibiltech. A judicial court in Paris, France, granted the liquidation of Cibiltech, which filed for bankruptcy. In the Settlement Agreement, Cibiltech irrevocably waived and relinquished any and all claims, demands, grievances, proceeding, actions or other requests, whether judicial, administrative, arbitral or otherwise, against the Company. The outstanding obligation of the Company with Cibiltech was waived and relinquished, except for $0.4 million, which was paid in July 2023, and represented the amount that the Company agreed to per the Settlement Agreement. There is no outstanding obligation as of September 30, 2023.

Other Commitments

Pursuant to the Illumina Agreement, the Company has agreed to minimum purchase commitments of finished products and raw materials from Illumina, Inc. through 2023.

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Litigation and Indemnification Obligations

In response to the Company’s false advertising suit filed against Natera Inc. (“Natera”) on April 10, 2019, Natera filed a counterclaim against the Company on February 18, 2020, in the U.S. District Court for the District of Delaware (the “Court”) alleging the Company made false and misleading claims about the performance capabilities of AlloSure. The suit seeks injunctive relief and unspecified monetary relief. On September 30, 2020, Natera requested leave of Court to amend its counterclaims to include additional allegations regarding purportedly false claims the Company made with respect to AlloSure, and the Court granted Natera’s request. The trial commenced on March 7, 2022 and concluded on March 14, 2022, with the jury finding that Natera violated the Lanham Act by falsely advertising the scientific performance of its Prospera transplant test and awarding the Company $44.9 million in damages, comprised of $21.2 million in compensatory damages and $23.7 million in punitive damages. In July 2023, the Court upheld and reaffirmed the March 2022 jury verdict but did not uphold the monetary damages awarded by the jury, which the Company intends to appeal. In August 2023, the Court issued an injunction prohibiting Natera from making the claims the jury previously found to be false advertising. The case is now on appeal.

On July 19, 2022, the U.S. Court of Appeals for the Federal Circuit affirmed the Court’s judgment dismissing the Company’s patent infringement suit against Natera. In May 2023, the Company submitted a petition of certiorari to the U.S. Supreme Court for consideration of the patent infringement suit and in October 2023, the U.S. Supreme Court declined to hear the suit.

In addition, Natera filed suit against the Company on January 13, 2020, in the Court alleging, among other things, that AlloSure infringes Natera’s U.S. Patent 10,526,658. This case was consolidated with the Company’s patent infringement suit on February 4, 2020. On March 25, 2020, Natera filed an amendment to the suit alleging, among other things, that AlloSure also infringes Natera’s U.S. Patent 10,597,724. The suit seeks a judgment that the Company has infringed Natera’s patents, an order preliminarily and permanently enjoining the Company from any further infringement of such patents and unspecified damages. On May 13, 2022, Natera filed two new complaints alleging that AlloSure infringes Natera’s U.S. Patents 10,655,180 and 11,111,544. These two cases were consolidated with the patent infringement case on June 15, 2022. On May 17, 2022, Natera agreed to dismiss the case alleging infringement of Natera’s U.S. Patent 10,526,658. On July 6, 2022, the Company moved to dismiss the rest of Natera’s claims. On September 6, 2022, the Company withdrew its motion to dismiss. The case is ongoing. The Company intends to defend both of these matters vigorously, and believes that the Company has good and substantial defenses to the claims alleged in the suits, but there is no guarantee that the Company will prevail. The Company has not recorded any liabilities for these suits.

United States Department of Justice and United States Securities and Exchange Commission Investigations

As previously disclosed, in 2021, the Company received a civil investigative demand (“CID”) from the United States Department of Justice (“DOJ”) requesting that the Company produce certain documents in connection with a False Claims Act investigation being conducted by the DOJ regarding certain business practices related to the Company’s kidney testing and phlebotomy services, and a subpoena from the United States Securities and Exchange Commission (the “SEC”) in relation to an investigation by the SEC in respect of matters similar to those identified in the CID, as well as certain of the Company’s accounting and public reporting practices. By letter dated September 19, 2023, the Company was notified by the staff of the SEC that the SEC has concluded its investigation as to the Company and does not intend to recommend an enforcement action by the SEC against the Company. The notice was provided under the guidelines set out in the final paragraph of Securities Act Release No. 5310.

The Company may receive additional requests for information from the DOJ, the SEC, or other regulatory and governmental agencies regarding similar or related subject matters. The Company does not believe that the CID raises any issues regarding the safety or efficacy of any of the Company’s products or services and are cooperating fully with the DOJ investigation. Although the Company remains committed to compliance with all applicable laws and regulations, it cannot predict the outcome of the DOJ investigation or any other requests or investigations that may arise in the future regarding these or other subject matters.

From time to time, the Company may become involved in litigation and other legal actions. The Company estimates the range of liability related to any pending litigation where the amount and range of loss can be estimated. The Company records its best estimate of a loss when the loss is considered probable. Where a liability is probable and there is a range of estimated loss with no best estimate in the range, the Company records a charge equal to at least the minimum estimated liability for a loss contingency when both of the following conditions are met: (i) information available prior to issuance of the condensed consolidated financial statements indicates that it is probable that a liability had been incurred at the date of the condensed consolidated financial statements, and (ii) the range of loss can be reasonably estimated.

Olymbios Matter

On April 15, 2022, a complaint was filed by Michael Olymbios against the Company in the Superior Court of the State of California for the County of San Mateo (the “San Mateo County Court”). The complaint alleges that the Company failed to pay certain fees and costs required to continue an arbitration proceeding against Dr. Olymbios, and that the Company has defamed

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Dr. Olymbios. Dr. Olymbios also seeks to void restrictive covenants previously agreed to by him in favor of the Company and to recover damages purportedly incurred by Dr. Olymbios. The Company filed a motion to compel arbitration and dismiss the case. On April 25, 2022, the San Mateo County Court granted the Company’s ex parte application to stay the case and advance the hearing date to June 10, 2022 for the motion to compel arbitration and dismiss. At the June 10, 2022 hearing, the San Mateo County Court found that the decision should be made by the arbitrator, and stayed the case. On July 19, 2022, Dr. Olymbios filed a motion to withdraw from arbitration before Judicial Arbitration and Mediation Services, Inc., which was denied on August 18, 2022. The matter is currently proceeding in arbitration. The Company intends to vigorously pursue its arbitration proceeding against Dr. Olymbios and to vigorously defend itself against Dr. Olymbios’ claims. The Company believes it has good and substantial support for its claims and good and substantial defenses to the claims alleged in the suit by Dr. Olymbios, but there is no guarantee that the Company will prevail if the case continues. The Company has not recorded any liabilities for this suit.

Securities Class Action

On May 23, 2022, Plumbers & Pipefitters Local Union #295 Pension Fund filed a federal securities class action in the U.S. District Court for the Northern District of California against the Company, Reginald Seeto, its former President, Chief Executive Officer and member of the Company’s Board of Directors, Ankur Dhingra, its former Chief Financial Officer, Marcel Konrad, its former interim Chief Financial Officer and former Senior Vice President of Finance & Accounting, and Peter Maag, its former President, former Chief Executive Officer, former Chairman of the Company’s Board of Directors and current member of the Company’s Board of Directors. The action alleges that the Company and the individual defendants made materially false and/or misleading statements and/or omissions and that such statements violated Section 10(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Rule 10b-5 promulgated thereunder. The action also alleges that the individual defendants are liable pursuant to Section 20(a) of the Exchange Act as controlling persons of the Company. The suit seeks to recover damages caused by the alleged violations of federal securities laws, along with the plaintiffs’ costs incurred in the lawsuit, including their reasonable attorneys’ and experts’ witness fees and other costs.

On August 25, 2022, the court appointed an investor group led by the Oklahoma Police Pension and Retirement System as lead plaintiffs and appointed Saxena White P.A. and Robbins Geller Rudman & Dowd LLP as lead counsels. Plaintiffs filed an amended complaint on November 28, 2022. On January 27, 2023, defendants moved to dismiss all claims and to strike certain allegations in the amended complaint.

On May 24, 2023, the court granted the Company’s motion to strike and motion to dismiss, dismissing all claims against defendants with leave to amend. On June 28, 2023, plaintiffs filed a second amended complaint against the Company, Reginald Seeto, Ankur Dhingra, and Peter Maag. Under a briefing schedule ordered by the court on June 12, 2023, defendants’ motion to dismiss and motion to strike the second amended complaint was filed on July 26, 2023, plaintiffs’ opposition was filed on August 30, 2023, and defendants’ reply was filed on September 22, 2023. The court held oral argument on October 31, 2023. The Company intends to defend itself vigorously, and believes that the Company has good and substantial defenses to the claims alleged in the suit, but there is no guarantee that the Company will prevail. The Company has not recorded any liabilities for this suit.

Derivative Actions

On September 21, 2022, Jeffrey Edelman brought a stockholder derivative action complaint in the U.S. District Court for the Northern District of California against the Company as nominal defendant and Drs. Seeto and Maag and Mr. Dhingra, and other current and former members of the Company’s Board of Directors (the “Edelman Derivative Action”). The plaintiff alleges that the individual defendants breached their fiduciary duties as directors and/or officers of the Company and engaged in insider trading, waste of corporate assets, unjust enrichment and violations of Sections 14(a) and 20(a) of the Exchange Act. The action alleges that the individual defendants are liable pursuant to Section 20(a) of the Exchange Act as controlling persons of the Company. The suit seeks a declaration that the individual defendants breached their fiduciary duties to the Company, violated Sections 14(a) and 20(a) of the Exchange Act and were unjustly enriched, and also seeks to recover damages sustained by the Company as a result of the alleged violations, along with the plaintiff’s costs incurred in the lawsuit, including reasonable attorneys’ and experts’ fees, costs and expenses.

On December 8, 2022, the court stayed the Edelman Derivative Action until 20 days after the earlier of the following events: (a) the securities class action is dismissed in its entirety with prejudice; (b) the motion to dismiss in the securities class action is denied; (c) a joint request by plaintiff and defendants to lift the stay; (d) notification that a related derivative action that has been filed is not stayed or is no longer stayed; or (e) notification that there has been a settlement reached in the securities class action or any related derivative action.

On February 7, 2023, Jaysen Stevenson brought a stockholder derivative action complaint in the U.S. District Court for the Northern District of California against the Company as nominal defendant and Drs. Seeto and Maag and Mr. Dhingra and other current and former members of the Company’s Board of Directors (the “Stevenson Derivative Action”). The claims and allegations in the Stevenson Derivative Action are substantially similar to those in the Edelman Derivative Action. The plaintiff

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alleges that the individual defendants breached their fiduciary duties as directors and/or officers of the Company and engaged in insider trading, waste of corporate assets, unjust enrichment and violations of Sections 14(a) and 20(a) of the Exchange Act. The suit seeks declaratory relief and to recover alleged damages sustained by the Company as a result of the alleged violations, along with the plaintiff’s costs incurred in the lawsuit, including reasonable attorneys’ and experts’ fees, costs and expenses.

On March 9, 2023, the court consolidated the Edelman Derivative Action and the Stevenson Derivative Action and stayed both actions pursuant to the terms of the stay order in the Edelman Derivative Action. The consolidated derivative action remains stayed. The parties in the Stevenson Derivative Action filed a joint status statement with the court on September 6, 2023.

The Company intends to defend itself vigorously, and believes that the Company has good and substantial defenses to the claims alleged in the suits, but there are no guarantees that the Company will prevail.

Insurance Matter

In December 2022, the Company filed a lawsuit against its Directors and Officers liability insurance carriers in San Mateo County Superior Court. The Company seeks a declaration that costs and fees incurred by the Company in responding to governmental investigatory requests are covered under its policies. The Company also asserts breach of contract against its primary insurer Great American Insurance Company for denying the claim. The policies provide up to $15 million in coverage limits. The Company intends to vigorously pursue its claims, and believes it has good and substantial support for its claims, but there is no guarantee that the Company will prevail in these claims.

The Company issues common stock warrants in connection with debt or equity financings to lenders, placement agents and investors. Issued warrants are considered standalone financial instruments and the terms of each warrant are analyzed for equity or liability classification in accordance with U.S. GAAP. Warrants that are classified as liabilities usually have various features that would require net-cash settlement by the Company. Warrants that are not liabilities, derivatives and/or meet the exception criteria are classified as equity. Warrants liabilities are remeasured at fair value at each period end with changes in fair value recorded in the condensed consolidated statements of operations until expired or exercised. Warrants that are classified as equity are valued at their relative fair value on the date of issuance, recorded in additional paid in capital and not remeasured.

In the three months ended September 30, 2023, no warrants to purchase shares of common stock were exercised. In the nine months ended September 30, 2023, warrants to purchase approximately 3,000 shares of common stock were exercised for cash proceeds of $4,000.

In the three and nine months ended September 30, 2022, no warrants to purchase shares of common stock were exercised.

As of September 30, 2023, no warrants to purchase common stock were outstanding.

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Stock Options and Restricted Stock Units (“RSU”)

The following table summarizes option and RSU activity under the Company’s 2014 Equity Incentive Plan, 2016 Inducement Equity Incentive Plan and 2019 Inducement Equity Incentive Plan, and related information:

			Shares Available for Grant						Stock Options Outstanding						Weighted- Average Exercise Price						Number of RSU Shares						Weighted- Average Grant Date Fair Value
Balance—December 31, 2022			1,490,462						2,921,925						$	28.13					3,094,396						$	37.39
Additional shares authorized			2,141,330						—						—						—						—
Common stock awards for services			(15,809)						—						—						—						—
RSUs granted			(3,461,674)						—						—						3,461,674						11.11
RSUs vested			—						—						—						(815,374)						35.90
Options granted			(680,788)						680,788						12.60						—						—
Options exercised			—						(23,203)						4.59						—						—
Repurchase of common stock under employee incentive plans			265,953						—						—						—						—
RSUs forfeited			761,771						—						—						(761,771)						24.67
Options forfeited			178,830						(178,830)						27.61						—						—
Options expired			236,645						(236,645)						26.93						—						—
Balance—September 30, 2023			916,720						3,164,035						$	25.18					4,978,925						$	21.24

The total intrinsic value of options exercised was $74,000 and $0.1 million for the three and nine months ended September 30, 2023, respectively. The total intrinsic value of options exercised was $0.1 million and $1.3 million for the three and nine months ended September 30, 2022, respectively.

As of September 30, 2023, the total intrinsic value of outstanding RSUs was approximately $35.8 million and there were $63.6 million of unrecognized compensation costs related to RSUs, which are expected to be recognized over a weighted-average period of 2.51 years.

Options outstanding that have vested and are expected to vest at September 30, 2023 are as follows:

			Number of Shares Issued (In thousands)						Weighted-Average Exercise Price						Weighted-Average Remaining Contractual Life (Years)						Aggregate Intrinsic Value (In thousands)
Vested			1,620						$	26.60					6.48						$	399
Expected to vest			1,378						23.50						8.84						—
Total			2,998																		$	399

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock options and the fair value of the Company’s common stock at September 30, 2023 for stock options that were in-the-money.

The total fair value of options that vested during the three and nine months ended September 30, 2023 was $3.2 million and $15.6 million, respectively. As of September 30, 2023, there were approximately $20.4 million of unrecognized compensation costs related to stock options, which are expected to be recognized over a weighted-average period of 2.40 years.

2014 Employee Stock Purchase Plan

The Company has an Employee Stock Purchase Plan (the “ESPP”), under which employees can purchase shares of its common stock based on a percentage of their compensation, but not greater than 15% of their respective earnings; provided, however, an eligible employee’s right to purchase shares of the Company’s common stock may not accrue at a rate which exceeds $25,000 of the fair market value of such shares for each calendar year in which such rights are outstanding. The ESPP has consecutive offering periods of approximately six months in length. The purchase price per share must be equal to the lower of 85% of the fair value of the common stock on the first day of the offering period or on the exercise date.

During the offering period in 2023 that ended on June 30, 2023, 143,817 shares were purchased pursuant to the ESPP for aggregate proceeds of $1.0 million from the issuance of such shares, which occurred on July 6, 2023.

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During the offering period in 2022 that ended on December 31, 2022, 47,025 shares were purchased pursuant to the ESPP for aggregate proceeds of $0.5 million from the issuance of such shares, which occurred on January 2, 2023.  

Valuation Assumptions

The estimated fair values of employee stock options and ESPP shares were estimated using the Black-Scholes option pricing model based on the following weighted average assumptions:

						Three Months Ended September 30,												Nine Months Ended September 30,
						2023						2022						2023						2022
Employee stock options
Expected term (in years)						N/A						6.0						5.6						6.0
Expected volatility						N/A						78.29%						77.86%						77.58%
Risk-free interest rate						N/A						2.99%						3.67%						2.69%
Expected dividend yield						N/A						—%						—%						—%
Employee stock purchase plan
Expected term (in years)						0.5						0.5						0.5						0.5
Expected volatility						93.38%						91.16%						93.38%						74.66%
Risk-free interest rate						5.53%						3.92%						5.49%						2.92%
Expected dividend yield						—%						—%						—%						—%

Risk-free Interest Rate: The Company based the risk-free interest rate over the expected term of the award based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of grant.

Volatility: The Company used an average historical stock price volatility of its own stock.

Expected Term: The expected term represents the period for which the Company’s stock-based compensation awards are expected to be outstanding and is based on analyzing the vesting and contractual terms of the awards and the holders’ historical exercise patterns and termination behavior.

Expected Dividends: The Company has not paid and does not anticipate paying any dividends in the near future.

Stock-Based Compensation Expense

The following table summarizes stock-based compensation expense relating to employee and non-employee stock-based awards for the three and nine months ended September 30, 2023 and 2022, included in the condensed consolidated statements of operations as follows (in thousands):

			Three Months Ended September 30,												Nine Months Ended September 30,
			2023						2022						2023						2022
Cost of testing services			$	496					$	470					$	1,467					$	1,055
Cost of product			301						321						935						851
Cost of patient and digital solutions			297						299						1,066						882
Research and development			1,491						2,058						5,157						6,571
Sales and marketing			3,041						2,672						9,557						9,702
General and administrative			7,045						5,380						20,943						15,366
Total			$	12,671					$	11,200					$	39,125					$	34,427

No tax benefit was recognized related to stock-based compensation expense since the Company has never reported taxable income and has established a full valuation allowance to offset all of the potential tax benefits associated with its deferred tax assets. In addition, no amounts of stock-based compensation expense were capitalized for the periods presented.

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including (i) cumulative results of operations in recent years, (ii) sources of recent losses, (iii) estimates of future taxable income, and (iv) the length of net operating loss carryforward periods. The Company believes that based on the history of its U.S. losses and other factors, the weight of available evidence indicates that it is more likely than not that it will not be able to realize its U.S. consolidated net deferred tax assets. Accordingly, the U.S. and Sweden net deferred tax assets have been offset by a full valuation allowance.

For the three and nine months ended September 30, 2023, the Company recorded an income tax benefit of $80,000 and $24,000, respectively. For the three and nine months ended September 30, 2022, the Company recorded an income tax expense of $0.3 million and $0.2 million, respectively. The income tax benefit of $80,000 and $24,000 for the three and nine months ended September 30, 2023, respectively, is primarily attributable to the U.S. current tax benefit resulting from the recently filed 2022 income tax returns and a U.S. deferred tax benefit resulting from the acquisition of MediGO in July 2023.

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Operating segments are defined as components of an enterprise for which separate financial information is available that is evaluated regularly by the Company’s Chief Operating Decision Maker (“CODM”), or decision making group, whose function is to allocate resources to and assess the performance of the operating segments. The Company has identified its Chief Executive Officer as the CODM. In determining its reportable segments, the Company considered the markets and types of customers served and the products or services provided in those markets. The Company operates in a single reportable segment.

Revenues by geographic regions are based upon the customers’ ship-to address for product revenue and the region of testing for testing services revenue. The following table summarizes reportable revenues by geographic regions (in thousands):

			Three Months Ended September 30,												Nine Months Ended September 30,
			2023						2022						2023						2022
Testing services revenue
United States			$	47,644					$	64,547					$	162,560					$	197,675
Rest of World			140						204						422						655
			$	47,784					$	64,751					$	162,982					$	198,330
Product revenue
United States			$	5,810					$	4,245					$	13,857					$	11,435
Europe			2,437						2,262						7,430						6,887
Rest of World			1,289						687						2,986						2,374
			$	9,536					$	7,194					$	24,273					$	20,696
Patient and digital solutions revenue
United States			$	9,735					$	7,187					$	27,130					$	19,865
Europe			34						209						239						429
Rest of World			103						18						131						89
			$	9,872					$	7,414					$	27,500					$	20,383
Total United States			$	63,189					$	75,979					$	203,547					$	228,975
Total Europe			$	2,471					$	2,471					$	7,669					$	7,316
Total Rest of World			$	1,532					$	909					$	3,539					$	3,118
Total			$	67,192					$	79,359					$	214,755					$	239,409

The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions (in thousands):

			September 30, 2023						December 31, 2022
Long-lived assets:
United States			$	34,815					$	35,020
Europe			471						405
Rest of World			69						104
Total			$	35,355					$	35,529

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In January 2023, the Company announced a restructuring plan that is intended to optimize costs and simplify its organizational and corporate structure. The restructuring plan includes the discontinuation of the Company’s operations in Fremantle, Australia, terminating its employees in that location and vacating its facilities there. The Company incurred immaterial restructuring charges for each of the three and nine months ended September 30, 2023. The Company expects to complete the closure of its Australia location in June 2024.

In May 2023, the Company announced a reduction of its U.S. workforce to simplify and streamline its organization and strengthen the overall effectiveness of its operations. The restructuring charges are primarily related to employee severance pay and related costs. As a result of this plan, the Company incurred $0.8 million in restructuring charges for the three months ended June 30, 2023. The Company did not incur any restructuring charges related to this plan in the three months ended September 30, 2023.

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v3.23.3

Cover - shares	9 Months Ended
	Sep. 30, 2023	Nov. 06, 2023
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2023
Document Transition Report	false
Entity File Number	001-36536
Entity Registrant Name	CAREDX, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	94-3316839
Entity Address, Address Line One	8000 Marina Boulevard, 4th Floor
Entity Address, City or Town	Brisbane
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94005
City Area Code	415
Local Phone Number	287-2300
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	CDNA
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		54,098,378
Amendment Flag	false
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3
Entity Central Index Key	0001217234
Current Fiscal Year End Date	--12-31

v3.23.3

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 75,980	$ 89,921
Marketable securities	192,204	203,168
Accounts receivable	51,694	66,312
Inventory	17,978	19,232
Prepaid and other current assets	7,310	9,216
Total current assets	345,166	387,849
Property and equipment, net	35,355	35,529
Operating leases right-of-use assets	30,973	34,689
Intangible assets, net	46,455	43,051
Goodwill	40,208	37,523
Restricted cash	582	522
Other assets	2,441	3,828
Total assets	501,180	542,991
Current liabilities:
Accounts payable	8,972	9,942
Accrued compensation	16,664	16,902
Accrued and other liabilities	47,038	49,131
Total current liabilities	72,674	75,975
Deferred tax liability	140	0
Common stock warrant liability	0	32
Deferred payments for intangible assets	4,735	2,418
Operating lease liability, less current portion	29,252	33,406
Other liabilities	245	249
Total liabilities	107,046	112,080
Commitments and contingencies (Note 9)
Stockholders’ equity:
Preferred stock: $0.001 par value; 10,000,000 shares authorized at September 30, 2023 and December 31, 2022; no shares issued and outstanding at September 30, 2023 and December 31, 2022	0	0
Common stock: $0.001 par value; 100,000,000 shares authorized at September 30, 2023 and December 31, 2022; 54,153,496 shares issued and outstanding at September 30, 2023; 53,583,301 shares issued and 53,533,250 shares outstanding at December 31, 2022	52	52
Additional paid-in capital	936,954	898,806
Accumulated other comprehensive loss	(8,670)	(7,503)
Accumulated deficit	(534,202)	(460,444)
Total stockholders’ equity	394,134	430,911
Total liabilities and stockholders’ equity	$ 501,180	$ 542,991

v3.23.3

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2023	Dec. 31, 2022
Statement of Financial Position [Abstract]
Preferred stock, par value (in usd per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in usd per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	100,000,000	100,000,000
Common stock, shares issued (in shares)	54,153,496	53,583,301
Common stock, shares outstanding (in shares)	54,153,496	53,533,250

v3.23.3

Condensed Consolidated Statements of Operations - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Revenue:
Total revenue	$ 67,192,000	$ 79,359,000	$ 214,755,000	$ 239,409,000
Operating expenses:
Research and development	19,000,000	22,306,000	63,590,000	66,818,000
Sales and marketing	18,474,000	22,261,000	63,335,000	72,359,000
General and administrative	33,968,000	23,830,000	91,327,000	75,621,000
Restructuring costs	0	0	848,000	0
Total operating expenses	95,975,000	96,698,000	295,486,000	297,520,000
Loss from operations	(28,783,000)	(17,339,000)	(80,731,000)	(58,111,000)
Other income (expense):
Interest income, net	3,171,000	1,225,000	8,708,000	1,892,000
Change in estimated fair value of common stock warrant liability	0	14,000	10,000	89,000
Other income (expense), net	2,047,000	(572,000)	(198,000)	(1,948,000)
Total other income	5,218,000	667,000	8,520,000	33,000
Loss before income taxes	(23,565,000)	(16,672,000)	(72,211,000)	(58,078,000)
Income tax benefit (expense)	80,000	(267,000)	24,000	(206,000)
Net loss	$ (23,485,000)	$ (16,939,000)	$ (72,187,000)	$ (58,284,000)
Net loss per share
Basic (in dollars per share)	$ (0.43)	$ (0.32)	$ (1.34)	$ (1.09)
Diluted (in dollars per share)	$ (0.43)	$ (0.32)	$ (1.34)	$ (1.09)
Weighted-average shares used to compute net loss per share:
Basic (in shares)	54,178,759	53,489,418	53,891,374	53,253,210
Diluted (in shares)	54,178,759	53,489,418	53,891,374	53,253,210
Testing services revenue
Revenue:
Total revenue	$ 47,784,000	$ 64,751,000	$ 162,982,000	$ 198,330,000
Operating expenses:
Cost of testing services, product, digital, and other	13,217,000	17,771,000	43,837,000	53,629,000
Product revenue
Revenue:
Total revenue	9,536,000	7,194,000	24,273,000	20,696,000
Operating expenses:
Cost of testing services, product, digital, and other	4,750,000	4,736,000	12,742,000	13,022,000
Patient and digital solutions revenue
Revenue:
Total revenue	9,872,000	7,414,000	27,500,000	20,383,000
Operating expenses:
Cost of testing services, product, digital, and other	$ 6,566,000	$ 5,794,000	$ 19,807,000	$ 16,071,000

v3.23.3

Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Statement of Comprehensive Income [Abstract]
Net loss	$ (23,485)	$ (16,939)	$ (72,187)	$ (58,284)
Other comprehensive loss:
Foreign currency translation adjustments, net of tax	(220)	(1,627)	(1,167)	(4,139)
Net comprehensive loss	$ (23,705)	$ (18,566)	$ (73,354)	$ (62,423)

v3.23.3

Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-In Capital	Accumulated Other Comprehensive Loss	Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2021		52,923,360
Beginning balance at Dec. 31, 2021	$ 465,876	$ 52	$ 853,683	$ (4,670)	$ (383,189)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock under employee stock purchase plan (in shares)		25,852
Issuance of common stock under employee stock purchase plan	999		999
RSU settlements, net of shares withheld (in shares)		64,819
RSU settlements, net of shares withheld	(1,482)		(1,482)
Issuance of common stock for services (in shares)		1,249
Issuance of common stock for services	58		58
Issuance of common stock for cash upon exercise of stock options (in shares)		69,993
Issuance of common stock for cash upon exercise of stock options	1,598		1,598
Employee stock-based compensation expense	10,563		10,563
Foreign currency translation adjustment	(420)			(420)
Net loss	(19,648)				(19,648)
Ending balance (in shares) at Mar. 31, 2022		53,085,273
Ending balance at Mar. 31, 2022	457,544	$ 52	865,419	(5,090)	(402,837)
Beginning balance (in shares) at Dec. 31, 2021		52,923,360
Beginning balance at Dec. 31, 2021	465,876	$ 52	853,683	(4,670)	(383,189)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Foreign currency translation adjustment	(4,139)
Net loss	(58,284)
Ending balance (in shares) at Sep. 30, 2022		53,523,453
Ending balance at Sep. 30, 2022	436,679	$ 52	886,909	(8,809)	(441,473)
Beginning balance (in shares) at Mar. 31, 2022		53,085,273
Beginning balance at Mar. 31, 2022	457,544	$ 52	865,419	(5,090)	(402,837)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
RSU settlements, net of shares withheld (in shares)		216,950
RSU settlements, net of shares withheld	(3,211)		(3,211)
Issuance of common stock for services (in shares)		2,156
Issuance of common stock for services	79		79
Issuance of common stock for cash upon exercise of stock options (in shares)		19,333
Issuance of common stock for cash upon exercise of stock options	413		413
Employee stock-based compensation expense	12,513		12,513
Foreign currency translation adjustment	(2,092)			(2,092)
Net loss	(21,697)				(21,697)
Ending balance (in shares) at Jun. 30, 2022		53,323,712
Ending balance at Jun. 30, 2022	443,549	$ 52	875,213	(7,182)	(424,534)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock under employee stock purchase plan (in shares)		67,570
Issuance of common stock under employee stock purchase plan	1,231		1,231
RSU settlements, net of shares withheld (in shares)		119,429
RSU settlements, net of shares withheld	(850)		(850)
Issuance of common stock for services (in shares)		3,545
Issuance of common stock for services	79		79
Issuance of common stock for cash upon exercise of stock options (in shares)		9,197
Issuance of common stock for cash upon exercise of stock options	139		139
Employee stock-based compensation expense	11,097		11,097
Foreign currency translation adjustment	(1,627)			(1,627)
Net loss	(16,939)				(16,939)
Ending balance (in shares) at Sep. 30, 2022		53,523,453
Ending balance at Sep. 30, 2022	$ 436,679	$ 52	886,909	(8,809)	(441,473)
Beginning balance (in shares) at Dec. 31, 2022	53,533,250	53,533,250
Beginning balance at Dec. 31, 2022	$ 430,911	$ 52	898,806	(7,503)	(460,444)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock under employee stock purchase plan (in shares)		47,025
Issuance of common stock under employee stock purchase plan	456		456
Repurchase and retirement of common stock (in shares)		(59,472)
Repurchase and retirement of common stock	(690)				(690)
RSU settlements, net of shares withheld (in shares)		123,910
RSU settlements, net of shares withheld	(785)		(785)
Issuance of common stock for services (in shares)		7,649
Issuance of common stock for services	93		93
Issuance of common stock for cash upon exercise of stock options (in shares)		820
Issuance of common stock for cash upon exercise of stock options	2		2
Employee stock-based compensation expense	13,719		13,719
Foreign currency translation adjustment	64			64
Net loss	(23,749)				(23,749)
Ending balance (in shares) at Mar. 31, 2023		53,653,182
Ending balance at Mar. 31, 2023	$ 420,021	$ 52	912,291	(7,439)	(484,883)
Beginning balance (in shares) at Dec. 31, 2022	53,533,250	53,533,250
Beginning balance at Dec. 31, 2022	$ 430,911	$ 52	898,806	(7,503)	(460,444)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock for cash upon exercise of stock options (in shares)	23,203
Foreign currency translation adjustment	$ (1,167)
Net loss	$ (72,187)
Ending balance (in shares) at Sep. 30, 2023	54,153,496	54,153,496
Ending balance at Sep. 30, 2023	$ 394,134	$ 52	936,954	(8,670)	(534,202)
Beginning balance (in shares) at Mar. 31, 2023		53,653,182
Beginning balance at Mar. 31, 2023	420,021	$ 52	912,291	(7,439)	(484,883)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Repurchase and retirement of common stock (in shares)		(12,000)
Repurchase and retirement of common stock	(67)				(67)
RSU settlements, net of shares withheld (in shares)		362,710
RSU settlements, net of shares withheld	(1,508)		(1,508)
Issuance of common stock for services (in shares)		3,647
Issuance of common stock for services	36		36
Issuance of common stock for cash upon exercise of stock options (in shares)		2,930
Issuance of common stock for cash upon exercise of stock options	6		6
Issuance of common stock for cash upon exercise of warrants (in shares)		3,132
Issuance of common stock for cash upon exercise of warrants	26		26
Employee stock-based compensation expense	12,663		12,663
Foreign currency translation adjustment	(1,011)			(1,011)
Net loss	(24,953)				(24,953)
Ending balance (in shares) at Jun. 30, 2023		54,013,601
Ending balance at Jun. 30, 2023	405,213	$ 52	923,514	(8,450)	(509,903)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock under employee stock purchase plan (in shares)		143,816
Issuance of common stock under employee stock purchase plan	1,039		1,039
Repurchase and retirement of common stock (in shares)		(92,766)
Repurchase and retirement of common stock	(814)				(814)
RSU settlements, net of shares withheld (in shares)		64,879
RSU settlements, net of shares withheld	(355)		(355)
Issuance of common stock for services (in shares)		4,513
Issuance of common stock for services	37		37
Issuance of common stock for cash upon exercise of stock options (in shares)		19,453
Issuance of common stock for cash upon exercise of stock options	99		99
Employee stock-based compensation expense	12,620		12,620
Foreign currency translation adjustment	(220)			(220)
Net loss	$ (23,485)				(23,485)
Ending balance (in shares) at Sep. 30, 2023	54,153,496	54,153,496
Ending balance at Sep. 30, 2023	$ 394,134	$ 52	$ 936,954	$ (8,670)	$ (534,202)

v3.23.3

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Operating activities:
Net loss	$ (72,187)	$ (58,284)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	39,125	34,427
Depreciation and amortization	10,755	8,389
Asset impairments and write-downs	1,000	840
Amortization of right-of-use assets	4,020	3,120
Unrealized loss on long-term marketable equity securities	1,185	215
Revaluation of contingent consideration to estimated fair value	1,731	830
Loss on disposal of asset	37
Gain on settlement of obligation and recovery of written-off investment	(2,109)	0
Accretion of discount and amortization of premium on short-term marketable securities, net	(3,410)	993
Revaluation of common stock warrant liability to estimated fair value	(10)	(89)
Changes in operating assets and liabilities:
Accounts receivable	15,351	(10,838)
Inventory	758	(2,258)
Prepaid and other assets	2,542	(397)
Operating leases liabilities, net	(4,088)	(2,390)
Accounts payable	(990)	(1,697)
Accrued compensation	(336)	(11,610)
Accrued and other liabilities	(3,462)	6,482
Change in deferred taxes	81	(157)
Net cash used in operating activities	(10,007)	(32,424)
Investing activities:
Acquisitions of business, net of cash acquired	(6,682)	(610)
Acquisitions of intangible assets	(896)	(3,100)
Purchases of short-term marketable securities	(192,131)	(283,442)
Maturities of short-term marketable securities	206,503	74,132
Purchase of corporate equity securities	(965)	0
Additions of capital expenditures	(6,750)	(17,957)
Net cash used in investing activities	(921)	(230,977)
Financing activities:
Proceeds from issuance of common stock under employee stock purchase plan	1,495	2,231
Taxes paid related to net share settlement of restricted stock units	(2,514)	(5,543)
Proceeds from exercise of warrants	4	0
Proceeds from exercise of stock options	107	2,149
Payment of contingent consideration	(250)	(1,000)
Repurchase and retirement of common stock	(1,571)	0
Net cash used in financing activities	(2,729)	(2,163)
Effect of exchange rate changes on cash and cash equivalents	(224)	25
Net decrease in cash, cash equivalents and restricted cash	(13,881)	(265,539)
Cash, cash equivalents and restricted cash at beginning of period	90,443	348,696
Cash, cash equivalents and restricted cash at end of period	$ 76,562	$ 83,157

v3.23.3

Organization and Description of Business	9 Months Ended
	Sep. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization and Description of Business	ORGANIZATION AND DESCRIPTION OF BUSINESS CareDx, Inc. (“CareDx” or the “Company”), together with its subsidiaries, is a leading precision medicine company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients and caregivers. The Company’s headquarters are in Brisbane, California. The primary operations are in Brisbane, California; Omaha, Nebraska; Fremantle, Australia; and Stockholm, Sweden. The Company’s commercially available testing services consist of AlloSure® Kidney, a donor-derived cell-free DNA (“dd-cfDNA”) solution for kidney transplant patients, AlloMap® Heart, a gene expression solution for heart transplant patients, AlloSure® Heart, a dd-cfDNA solution for heart transplant patients, and AlloSure® Lung, a dd-cfDNA solution for lung transplant patients. The Company has initiated several clinical studies to generate data on its existing and planned future testing services. In April 2020, the Company announced its first biopharma research partnership for AlloCell, a surveillance solution that monitors the level of engraftment and persistence of allogeneic cells for patients who have received cell therapy transplants. The Company also offers high-quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. The Company also provides digital solutions to transplant centers following the acquisitions of Ottr Complete Transplant Management (“Ottr”) and XynManagement, Inc. (“XynManagement”), as well as the acquisitions of TransChart LLC (“TransChart”), MedActionPlan.com, LLC (“MedActionPlan”) and The Transplant Pharmacy, LLC (“TTP”) in 2021, HLA Data Systems, LLC (“HLA Data Systems”) in January 2023 and MediGO, Inc. (“MediGO”) in July 2023. Testing Services AlloSure Kidney has been a covered service for Medicare beneficiaries since October 2017 through a Local Coverage Determination (“LCD”) first issued by Palmetto MolDX (“MolDX”), which was formed to identify and establish coverage and reimbursement for molecular diagnostics tests, and then adopted by Noridian Healthcare Solutions, the Company’s Medicare Administrative Contractor (“Noridian”). The Medicare reimbursement rate for AlloSure Kidney is currently $2,841. AlloMap Heart has been a covered service for Medicare beneficiaries since January 2006. The Medicare reimbursement rate for AlloMap Heart is currently $3,240. In October 2020, the Company received a final MolDX Medicare coverage decision for AlloSure Heart. Noridian issued a parallel coverage policy granting coverage for AlloSure Heart when used in conjunction with AlloMap Heart, which became effective in December 2020. In 2021, Palmetto and Noridian issued coverage policies written by MolDX to replace the former product-specific policies. The common policy LCD is titled “MolDX: Molecular Testing for Solid Organ Allograft Rejection” and the associated LCD numbers are L38568 (MolDX) and L38629 (Noridian). The Medicare reimbursement rate for AlloSure Heart is currently $2,753. Effective May 9, 2023, AlloSure Lung is covered for Medicare beneficiaries through the same MolDX LCD (Noridian L38629). The Medicare reimbursement rate for AlloSure Lung is $2,753. Effective April 1, 2023, HeartCare, a multimodality testing service that includes both AlloMap Heart and AlloSure Heart provided in a single patient encounter for heart transplant surveillance, is covered, subject to certain limitations, for Medicare beneficiaries through the same MolDX LCD (Noridian L38629). The Medicare reimbursement rate for HeartCare is $5,993. On March 2, 2023, MolDX issued a new billing article, with an effective date of March 31, 2023, related to the LCD entitled Molecular Testing for Solid Organ Allograft Rejection (the “Billing Article”). Prior to the Billing Article’s effective date, MolDX informed the affected parties, including CareDx, that enforcement of the revised billing practices outlined in the Billing Article would not be implemented until June 30, 2023. MolDX informed CareDx that its automatic adjudication process would remain in place until June 30, 2023, though claims submitted prior to that date must comply with the applicable LCDs. On May 4, 2023, MolDX issued a revised new billing article with an effective date of March 31, 2023 (the “Revised Billing Article” and together with the Billing Article, the “Billing Articles”). The Revised Billing Article impacts Medicare coverage for AlloSure Kidney, AlloSure Heart and AlloMap Heart and requires certain companies, including CareDx, to implement new processes to address the requirements related to Medicare claim submissions. MolDX has stated that it views the Billing Article as clarifying existing coverage, especially as it relates to when tests are covered in the for-cause and surveillance contexts. MolDX has acknowledged, however, that the Billing Article is a change as it relates to billing more than one test during a single patient encounter. Noridian adopted the Revised Billing Article on August 17, 2023, with a retroactive effective date of March 31, 2023. Although the Company believes the Billing Articles are inconsistent with the LCDs, Noridian’s and MolDX’s responses to public comments explaining the intended scope of various LCDs, and medical necessity, the Company determined to pause its Medicare reimbursement submissions for AlloSure Kidney commencing on March 7, 2023 to allow the Company further time to evaluate the implications of the Billing Article and update its billing processes for AlloSure Kidney tests by educating clinicians and working with centers to update CareDx’s test order forms to capture the new information required under the Billing Article. Accordingly, the Company did not submit claims for approximately 3,200 AlloSure Kidney tests for Medicare reimbursement for the period from March 7, 2023 through March 31, 2023 and did not recognize revenue on these claims in the first quarter of 2023 aggregating to approximately $8.9 million (the “Impacted March Tests”). On May 18, 2023, the Company submitted a letter to Noridian explaining, among other things, (i) the Company’s belief that the Billing Articles impose new restrictions on Medicare coverage for the CareDx tests from those contained in the existing LCDs, (ii) that the Company planned to submit claims for reimbursement for the Impacted March Tests for which the Company has not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing Articles, and (iii) that AlloSure Kidney orders with a date of service on or after March 31, 2023 for other indications outside the parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article. Following the submission of this letter to Noridian on May 18, 2023, the Company submitted claims for reimbursement for the Impacted March Tests for which the Company subsequently received payment from Noridian and recognized revenue totaling approximately $7.8 million in the second quarter of 2023. The Company has certain unbilled AlloSure Kidney claims with a service date after March 31, 2023, where the reason for testing is not specified by the ordering physician. The Company is in the process of supplementation for these tests. If these AlloSure Kidney tests are within the parameters of the Revised Billing Article, the Company will bill and would expect to recognize revenue in the quarter that the supplementation is completed. CareDx continued the Medicare reimbursement submissions for AlloMap Heart or AlloSure Heart following the issuance of the Billing Articles. In addition, CareDx informed Noridian on May 18, 2023 that until Noridian adopted the Revised Billing Article, CareDx would continue to submit AlloSure Heart tests for reimbursement only when used in conjunction with AlloMap Heart according to requirements of the Billing Article currently effective at Noridian. The Company also informed Noridian on May 18, 2023 that (i) until June 30, 2023, it planned to submit claims for reimbursement for AlloMap Heart and AlloSure Heart tests for which the Company has not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing Articles, and (ii) AlloSure Heart and AlloMap Heart orders placed on or after June 30, 2023 for other indications outside the surveillance and for-cause parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article. On August 28, 2023, the Company submitted a subsequent letter to Noridian regarding its AlloSure Heart and AlloMap Heart testing submissions, explaining, among other things, that (i) prior to August 17, 2023, the Company submitted claims as outlined in its prior communications, including submitting AlloSure Heart and AlloMap Heart claims that were in compliance with the billing article in effect for Noridian (but that were not necessarily in compliance with the Revised Billing Article that had not yet been adopted by Noridian); (ii) for claims with dates of service of August 17, 2023 or later, the Company is submitting AlloSure Heart and AlloMap Heart testing claims in compliance with the Revised Billing Article, including submitting AlloSure Heart claims when not used in conjunction with AlloMap Heart, and submitting HeartCare (AlloSure Heart and AlloMap Heart used together in a single patient encounter) claims for surveillance testing in lieu of a biopsy from 55 days to 370 days post-transplant; and (iii) for AlloSure Heart and AlloMap Heart tests performed on or after August 17, 2023 that are outside the parameters of the Revised Billing Article, certain billing codes will be used to enable any additional review deemed appropriate by Noridian and potential appeal by the Company of the denied claims. On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto; DL38629, Noridian) that, if adopted, would revise the existing foundational LCD, MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629). On August 14, 2023, MolDX released a draft billing article (DA58019) to accompany the proposed draft LCD, which generally reflected the changes in coverage included in the Revised Billing Article. The comment period end date for this proposed LCD was September 23, 2023. The Company presented at public meetings regarding the proposed draft LCD held on September 18, 2023 and September 20, 2023, with MolDX and Noridian, respectively. The Company also submitted written comments on the proposed draft LCD. AlloSure Kidney has received positive coverage decisions from several commercial payers, and is reimbursed by other private payers on a case-by-case basis. AlloMap Heart has also received positive coverage decisions for reimbursement from many of the largest U.S. private payers. In May 2021 and March 2023, the Company purchased a minority investment of common stock in the biotechnology company Miromatrix Medical, Inc. (“Miromatrix”), for an aggregate amount of $5.1 million, and the investment is marked to market. Miromatrix works to eliminate the need for an organ transplant waiting list through the development of implantable engineered biological organs. Clinical Studies In January 2018, the Company initiated the Kidney Allograft Outcomes AlloSure Kidney Registry study (“K-OAR”) to develop additional data on the clinical utility of AlloSure Kidney for surveillance of kidney transplant recipients. K-OAR is a multicenter, non-blinded, prospective observational cohort study which has enrolled more than 1,700 renal transplant patients who will receive AlloSure Kidney long-term surveillance. In September 2018, the Company initiated the Surveillance HeartCare™ Outcomes Registry (“SHORE”). SHORE is a prospective, multi-center, observational registry of patients receiving HeartCare for surveillance. HeartCare combines the gene expression profiling technology of AlloMap Heart with the dd-cfDNA analysis of AlloSure® Heart in one surveillance solution. In September 2019, the Company announced the commencement of the Outcomes of KidneyCare on Renal Allografts (“OKRA”) study, which is an extension of K-OAR. OKRA is a prospective, multi-center, observational, registry of patients receiving KidneyCare for surveillance. KidneyCare combines the dd-cfDNA analysis of AlloSure Kidney with the gene expression profiling technology of AlloMap Kidney and the predictive artificial intelligence technology of iBox for a multimodality surveillance solution. The Company has not yet made any applications to private payers for reimbursement coverage of AlloMap Kidney or KidneyCare. Products The Company’s suite of AlloSeq products are commercial next generation sequencing (“NGS”)-based kitted solutions. These products include: AlloSeq™ Tx, a high-resolution Human Leukocyte Antigen (“HLA”) typing solution, AlloSeq™ cfDNA, a surveillance solution designed to measure dd-cfDNA in blood to detect active rejection in transplant recipients, and AlloSeq™ HCT, a solution for chimerism testing for stem cell transplant recipients. The Company’s other HLA typing products include: Olerup SSP®, based on the sequence specific primer (“SSP”) technology; and QTYPE®, which uses real-time polymerase chain reaction (“PCR”) methodology, to perform HLA typing. In March 2021, the Company acquired certain assets of BFS Molecular S.R.L. (“BFS Molecular”), a software company focused on NGS-based patient testing solutions. BFS Molecular brings extensive software and algorithm development capabilities for NGS transplant surveillance products. Patient and Digital Solutions Following the acquisitions of both Ottr and XynManagement, the Company is a leading provider of transplant patient management software (“Ottr software”), as well as of transplant quality tracking and waitlist management solutions. Ottr software provides comprehensive solutions for transplant patient management and enables integration with electronic medical record (“EMR”) systems providing patient surveillance management tools and outcomes data to transplant centers. XynManagement provides two unique solutions, XynQAPI software (“XynQAPI”) and XynCare. XynQAPI simplifies transplant quality tracking and Scientific Registry of Transplant Recipients reporting. XynCare includes a team of transplant assistants who maintain regular contact with patients on the waitlist to help prepare for their transplant and maintain eligibility. In September 2020, the Company launched AlloCare, a mobile app that provides a patient-centric resource for transplant recipients to manage medication adherence, coordinate with Patient Care Managers for AlloSure scheduling and measure health metrics. In January 2021, the Company acquired TransChart. TransChart provides EMR software to hospitals throughout the U.S. to care for patients who have or may need an organ transplant. As part of the Company’s acquisition of TransChart in January 2021, the Company acquired TxAccess, a cloud-based service that allows nephrologists and dialysis centers to electronically submit referrals to transplant programs and closely follow and assist patients through the transplant waitlist process and, ultimately, through transplantation. In June 2021, the Company acquired the Transplant Hero patient application. The application helps patients manage their medications through alarms and interactive logging of medication events. Also in June 2021, the Company entered into a strategic agreement with OrganX, which was amended in April 2022, to develop clinical decision support tools across the transplant patient journey. Together, the Company and OrganX will develop advanced analytics that integrate AlloSure, the first transplant-specific dd-cfDNA assay, with large transplant databases to provide clinical data solutions. This partnership delivers the next level of innovation beyond multi-modality by incorporating a variety of clinical inputs to create a universal composite scoring system. The Company has agreed to potential future milestone payments. In November 2021, the Company acquired MedActionPlan, a New Jersey-based provider of medication safety, medication adherence and patient education. MedActionPlan is a leader in patient medication management for transplant patients and beyond. In December 2021, the Company acquired TTP, a transplant-focused pharmacy located in Mississippi. TTP provides individualized transplant pharmacy services for patients at multiple transplant centers located throughout the U.S. In January 2023, the Company acquired HLA Data Systems, a Texas-based company that provides software and interoperability solutions for the histocompatibility and immunogenetics community. HLA Data Systems is a leader in the laboratory information management industry for human leukocyte antigen laboratories. In July 2023, the Company acquired MediGO, an organ transplant supply chain and logistics company. MediGO provides access to donated organs by digitally transforming donation and transplantation workflows to increase organ utilization. Liquidity and Capital Resources The Company has incurred significant losses and negative cash flows from operations since its inception and had an accumulated deficit of $534.2 million at September 30, 2023. As of September 30, 2023, the Company had cash, cash equivalents and marketable securities of $268.2 million and no debt outstanding. Shelf Registration Statement On May 10, 2023, the Company filed a universal shelf registration statement (File No. 333-271814) (the “Registration Statement”), whereby the Company can sell from time to time shares of its common stock, preferred stock, debt securities, warrants, units or rights comprised of any combination of these securities, for the Company’s own account in one or more offerings under the Registration Statement. The terms of any offering under the Registration Statement will be established at the time of such offering and will be described in a prospectus supplement to the Registration Statement filed with the Securities and Exchange Commission (the “SEC”) prior to the completion of any such offering. Stock Repurchase Program On December 3, 2022, the Company’s Board of Directors approved a stock repurchase program (the “Repurchase Program”), whereby the Company may purchase up to $50 million of shares of its common stock over a period of up to two years, commencing on December 8, 2022. The Repurchase Program may be carried out at the discretion of a committee of the Company’s Board of Directors through open market purchases, one or more Rule 10b5-1 trading plans and block trades and in privately negotiated transactions. During the three and nine months ended September 30, 2023, the Company purchased an aggregate of 92,766 shares and 164,238 shares of its common stock, respectively, under the Repurchase Program for an aggregate purchase price of $0.8 million and $1.6 million, respectively. As of September 30, 2023, $47.7 million remained available for future share repurchase under the Repurchase Program.

v3.23.3

Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 2023
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The significant accounting policies and estimates used in preparation of the unaudited condensed consolidated financial statements are described in the Company’s audited consolidated financial statements as of and for the year ended December 31, 2022, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 27, 2023. Material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 are reflected below. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”), and follow the requirements of the SEC for interim reporting. As permitted under those rules, certain notes and other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of the Company’s financial information. The condensed consolidated balance sheet as of December 31, 2022 has been derived from audited consolidated financial statements as of that date but does not include all of the financial information required by U.S. GAAP for complete financial statements. Operating results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the unaudited condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to transaction price estimates used for testing services revenue; standalone fair value of patient and digital solutions revenue performance obligations; accrued expenses for clinical studies; inventory valuation; the fair value of issued common stock warrants and embedded derivatives; the fair value of assets and liabilities acquired in a business combination or an assets acquisition (including identifiable intangible assets acquired); the fair value of contingent consideration recorded in connection with a business combination or an asset acquisition; the grant date fair value assumptions used to estimate stock-based compensation expense; income taxes; impairment of long-lived assets and indefinite-lived assets (including goodwill); and legal contingencies. Actual results could differ from those estimates. Concentrations of Credit Risk and Other Risks and Uncertainties For the three months ended September 30, 2023 and 2022, approximately 36% and 53%, respectively, of total revenue was derived from Medicare. For the nine months ended September 30, 2023 and 2022, approximately 41% and 54%, respectively, of total revenue was derived from Medicare. As of September 30, 2023 and December 31, 2022, approximately 36% and 27%, respectively, of accounts receivable was due from Medicare. No other payer or customer represented more than 10% of accounts receivable at either September 30, 2023 or December 31, 2022. Marketable Securities The Company considers all highly liquid investments in securities with a maturity of greater than three months at the time of purchase to be marketable securities. As of September 30, 2023, the Company’s short-term marketable securities consisted of corporate debt securities with maturities of greater than three months but less than twelve months at the time of purchase, which were classified as current assets on the condensed consolidated balance sheet. The Company classifies its short-term marketable securities as held-to-maturity at the time of purchase and reevaluates such designation at each balance sheet date. The Company has the positive intent and ability to hold these marketable securities to maturity. Short-term marketable securities are carried at amortized cost and are adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income (expense), net on the condensed consolidated statements of operations. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on short-term marketable securities are included in interest income (expense), net. The cost of securities sold will be determined using specific identification. The Company considers investments in securities with remaining maturities of over one year as long-term investments. As of September 30, 2023, the Company’s long-term marketable securities consisted of corporate equity securities and corporate debt securities. These long-term marketable securities are classified as other assets on the condensed consolidated balance sheet. The Company classifies its long-term marketable debt securities as available-for-sale and reevaluates such designation at each balance sheet date. Unrealized gains and losses from the reevaluation of the long-term marketable debt securities, if any, are included in other comprehensive gain (loss) in the condensed consolidated statement of comprehensive income (loss). Realized gains and losses and declines in value judged to be other-than-temporary, if any, on long-term marketable securities are included in interest income (expense), net. The Company records its long-term marketable equity securities at fair market value. Unrealized gains and losses from the remeasurement of the long-term marketable equity securities to fair value are included in other income (expense), net, in the condensed consolidated statements of operations. Leases The Company adopted Accounting Standard Codification (“ASC”) Topic 842, Leases, and determines if an arrangement is or contains a lease at contract inception. A right-of-use (“ROU”) asset, representing the underlying asset during the lease term, and a lease liability, representing the payment obligation arising from the lease, are recognized on the condensed consolidated balance sheet at lease commencement based on the present value of the payment obligation. For operating leases, expense is recognized on a straight-line basis over the lease term. For finance leases, interest expense on the lease liability is recognized using the effective interest method and amortization of the ROU asset is recognized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. The Company also has lease arrangements with lease and non-lease components. The Company elected the practical expedient not to separate non-lease components from lease components for the Company’s facility leases. The Company also elected to apply the short-term lease measurement and recognition exemption in which ROU assets and lease liabilities are not recognized for leases with an initial term of 12 months or less. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment. As of September 30, 2023, the Company’s leases had remaining terms of 0.17 years to 9.35 years, some of which include options to extend the lease term. Revenue The Company recognizes revenue from testing services, product sales and patient and digital solutions revenue in the amount that reflects the consideration that it expects to be entitled in exchange for goods or services as it transfers control to its customers. Revenue is recorded considering a five-step revenue recognition model that includes identifying the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price to the performance obligations and recognizing revenue when, or as, an entity satisfies a performance obligation. Testing Services Revenue AlloSure Kidney, AlloMap Heart, AlloSure Heart and AlloSure Lung patient tests are ordered by healthcare providers. The Company receives a test requisition form with payer information along with a collected patient blood sample. The Company considers the patient to be its customer and the test requisition form to be the contract. Testing services are performed in the Company’s laboratory. Testing services represent one performance obligation in a contract and are performed when results of the test are provided to the healthcare provider, at a point in time. The healthcare providers that order the tests and on whose behalf the Company provides testing services are generally not responsible for the payment of these services. The first and second revenue recognition criteria are satisfied when the Company receives a test requisition form with payer information from the healthcare provider. Generally, the Company bills third-party payers upon delivery of an AlloSure Kidney, AlloMap Heart, AlloSure Heart or AlloSure Lung test result to the healthcare provider. Amounts received may vary amongst payers based on coverage practices and policies of the payer. The Company has used the portfolio approach under ASC Topic 606, Revenue from Contracts with Customers, to identify financial classes of payers. Revenue recognized for Medicare and other contracted payers is based on the agreed current reimbursement rate per test, adjusted for historical collection trends where applicable. The Company estimates revenue for non-contracted payers and self-payers using transaction prices determined for each financial class of payers using history of reimbursements. This includes analysis of an average reimbursement per test and a percentage of tests reimbursed. This estimate requires significant judgment. The Company monitors revenue estimates at each reporting period based on actual cash collections in order to assess whether a revision to the estimate is required. Changes in transaction price estimates are updated quarterly based on actual cash collected or changes made to contracted rates. On March 2, 2023, MolDX issued a new Billing Article, with an effective date of March 31, 2023. The Billing Article impacts Medicare coverage for AlloSure Kidney, AlloSure Heart and AlloMap Heart and requires the Company to implement new processes to address requirements related to Medicare claim submissions. ASC 606-10-25-1 requires the Company to assess whether it is probable that it will collect substantially all of the consideration to which it will be entitled when determining if a contract with a customer exists. Based upon the Company’s review of the Billing Article, it was determined to pause Medicare reimbursement submissions for AlloSure Kidney commencing on March 7, 2023 that created uncertainty around the collection of the claims. Accordingly, the Company did not submit claims for approximately 3,200 AlloSure Kidney tests for Medicare reimbursement for the period from March 7, 2023 through March 31, 2023 and did not recognize revenue on these claims in the first quarter of 2023 aggregating to approximately $8.9 million. On May 18, 2023, the Company submitted a letter to Noridian explaining, among other things, (i) the Company’s belief that the Billing Articles imposed new restrictions on Medicare coverage for the CareDx tests from those contained in the existing LCDs, (ii) that the Company planned to submit claims for reimbursement for the Impacted March Tests for which the Company has not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing Articles, and (iii) that AlloSure Kidney orders with a date of service on or after March 31, 2023 for other indications outside the parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article. Following the submission of this letter to Noridian, on May 18, 2023, the Company submitted claims for reimbursement for the Impacted March Tests, for which the Company subsequently received payment from Noridian and recognized revenue totaling approximately $7.8 million in the second quarter of 2023. The Company has certain unbilled AlloSure Kidney claims with a service date after March 31, 2023, where the reason for testing is not specified by the ordering physician. The Company is in the process of supplementation for these tests. If these AlloSure Kidney tests are within the parameters of the Revised Billing Article, the Company will bill and would expect to recognize revenue in the quarter that the supplementation is completed. The Company continues its Medicare reimbursement submissions for AlloMap Heart or AlloSure Heart following the issuance of the Billing Articles. In addition, the Company informed Noridian on May 18, 2023 that until Noridian adopted the Revised Billing Article, the Company would continue to submit AlloSure Heart tests for reimbursement only when used in conjunction with AlloMap Heart. The Company also informed Noridian on May 18, 2023 that (i) until June 30, 2023, it planned to submit claims for reimbursement for AlloMap Heart and AlloSure Heart tests for which the Company has not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing Articles, and (ii) AlloSure Heart and AlloMap Heart orders placed on or after June 30, 2023 for other indications outside the surveillance and for-cause parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article. On August 28, 2023, the Company submitted a subsequent letter to Noridian regarding its AlloSure Heart and AlloMap Heart testing submissions, explaining, among other things, that (i) prior to August 17, 2023, the Company submitted claims as outlined in its prior communications, including submitting AlloSure Heart and AlloMap Heart claims that were in compliance with the billing article in effect for Noridian (but that were not necessarily in compliance with the Revised Billing Article that had not yet been adopted by Noridian); (ii) for claims with dates of service of August 17, 2023 or later, the Company is submitting AlloSure Heart and AlloMap Heart testing claims in compliance with the Revised Billing Article, including submitting AlloSure Heart claims when not used in conjunction with AlloMap Heart, and submitting HeartCare (AlloSure Heart and AlloMap Heart used together in a single patient encounter) claims for surveillance testing in lieu of a biopsy from 55 days to 370 days post-transplant; and (iii) for AlloSure Heart and AlloMap Heart tests performed on or after August 17, 2023 that are outside the parameters of the Revised Billing Article, certain billing codes will be used to enable any additional review deemed appropriate by Noridian and potential appeal by the Company of the denied claims. On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto; DL38629, Noridian) that, if adopted, would revise the existing foundational LCD, MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629). On August 14, 2023, MolDX released a draft billing article (DA58019) to accompany the proposed draft LCD, which generally reflected the changes in coverage included in the Revised Billing Article. The comment period end date for this proposed LCD was September 23, 2023. The Company presented at public meetings regarding the proposed draft LCD held on September 18, 2023 and September 20, 2023, with MolDX and Noridian, respectively. The Company also submitted written comments on the proposed draft LCD. Product Revenue Product revenue is recognized from the sale of products to end-users, distributors and strategic partners when all revenue recognition criteria are satisfied. The Company generally has a contract or a purchase order from a customer with the specified required terms of order, including the number of products ordered. Transaction prices are determinable and products are delivered and the risk of loss is passed to the customer upon either shipping or delivery, as per the terms of the agreement. Patient and Digital Solutions Revenue Patient and digital solutions revenue is mainly derived from a combination of software as a service (“SaaS”) and perpetual software license agreements entered into with various transplant centers, which are the Company’s customers for this class of revenue. The main performance obligations in connection with the Company’s SaaS and perpetual software license agreements are the following: (i) implementation services and delivery of the perpetual software license, which are considered a single performance obligation, and (ii) post contract support. The Company allocates the transaction price to each performance obligation based on relative stand-alone selling prices of each distinct performance obligation. Digital revenue in connection with perpetual software license agreements is recognized over time based on the Company’s satisfaction of each distinct performance obligation in each agreement. Perpetual software license agreements typically require advance payments from customers upon the achievement of certain milestones. The Company records deferred revenue in relation to these agreements when cash payments are received or invoices are issued in advance of the Company’s performance, and generally recognizes revenue over the contractual term, as performance obligations are fulfilled. In addition, the Company derives patient and digital solutions revenue from software subscriptions and medication sales. The Company generally bills software subscription fees in advance. Revenue from software subscriptions is deferred and recognized ratably over the subscription term. The medication sales revenue is recognized based on the negotiated contract price with the governmental, commercial and non-commercial payers with any applicable patient co-pay. The Company recognizes revenue from medication sales when prescriptions are delivered. Recent Accounting Pronouncements There were no recently adopted accounting standards which would have a material effect on the Company’s condensed consolidated financial statements and accompanying disclosures, and no recently issued accounting standards that are expected to have a material impact on the Company’s condensed consolidated financial statements and accompanying disclosures.

v3.23.3

Net Loss Per Share	9 Months Ended
	Sep. 30, 2023
Earnings Per Share [Abstract]
Net Loss Per Share	NET LOSS PER SHARE Basic and diluted net loss per share have been computed by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common share equivalents as their effect would have been antidilutive. The following tables set forth the computation of the Company’s basic and diluted net loss per share (in thousands, except shares and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net loss used to compute basic and diluted net loss per share $ (23,485) $ (16,939) $ (72,187) $ (58,284) Denominator: Weighted-average shares used to compute basic and diluted net loss per share 54,178,759  53,489,418  53,891,374  53,253,210  Net loss per share: Basic and diluted $ (0.43) $ (0.32) $ (1.34) $ (1.09) The following potentially dilutive securities have been excluded from diluted net loss per share as of September 30, 2023 and 2022 because their effect would be antidilutive: Three and Nine Months Ended September 30, 2023 2022 Shares of common stock subject to outstanding options 3,167,977  3,116,421  Shares of common stock subject to outstanding common stock warrants —  3,132  Restricted stock units 4,977,616  3,077,633  Total common stock equivalents 8,145,593  6,197,186

v3.23.3

Fair Value Measurements	9 Months Ended
	Sep. 30, 2023
Fair Value Disclosures [Abstract]
Fair Value Measurements	FAIR VALUE MEASUREMENTS The Company records its financial assets and liabilities at fair value. The carrying amounts of certain financial instruments of the Company, including cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: •Level 1: Inputs that include quoted prices in active markets for identical assets and liabilities. •Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. •Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The following tables set forth the Company’s financial assets and liabilities, measured at fair value on a recurring basis, as of September 30, 2023 and December 31, 2022 (in thousands): September 30, 2023 Fair Value Measured Using   (Level 1) (Level 2) (Level 3) Total Balance Assets         Cash equivalents: Money market funds $ 54,405  $ —  $ —  $ 54,405  Long-term marketable securities: Corporate equity securities 992  —  —  992  Total $ 55,397  $ —  $ —  $ 55,397  Liabilities Short-term liabilities: Contingent consideration $ —  $ —  $ 2,083  $ 2,083  Long-term liabilities: Contingent consideration —  —  4,735  4,735  Total $ —  $ —  $ 6,818  $ 6,818  December 31, 2022   Fair Value Measured Using     (Level 1) (Level 2) (Level 3) Total Balance Assets         Cash equivalents: Money market funds $ 66,594  $ —  $ —  $ 66,594  Long-term marketable securities: Corporate equity securities 2,076  —  —  2,076  Total $ 68,670  $ —  $ —  $ 68,670  Liabilities Short-term liabilities: Contingent consideration $ —  $ —  $ 1,025  $ 1,025  Long-term liabilities: Contingent consideration —  —  2,418  2,418  Common stock warrant liability —  —  32  32  Total $ —  $ —  $ 3,475  $ 3,475  The following table presents the issuances, exercises, changes in fair value and reclassifications of the Company’s Level 3 financial instruments that are measured at fair value on a recurring basis (in thousands):   (Level 3) Common Stock Warrant Liability and Contingent Consideration Balance as of December 31, 2022 $ 3,475  Exercise of warrants (22) Change in estimated fair value of common stock warrant liability (10) Change in estimated fair value of contingent consideration 1,731  Addition of estimated fair value of contingent consideration 2,269  Payments related to contingent consideration (625) Balance as of September 30, 2023 $ 6,818  During March 2023, the Company wrote off $1.0 million of its investment in convertible preferred shares of Cibiltech SAS (“Cibiltech”), which was carried at cost. Cibiltech’s operations have been liquidated. The fair value of this investment was based on Level 3 inputs. In July 2023, the Company entered into a Securities Holders’ Agreement (the “Agreement”) with a private entity based in France. The private entity was established to continue Cibiltech's activity, which consists of designing, developing, publishing, promoting, distributing, and marketing of software related to predictive solutions, to monitoring and/or to remote monitoring in the field of human organ allotrasplantation, allografting, and chronic organ diseases. The private entity retained all assets of Cibiltech, including its licenses. Pursuant to the Agreement, the Company agreed to invest a certain amount in the private entity, in order to continue the commercialization of the iBox technology. The Company's investment is in the form of ordinary and Class B shares carried at cost. This investment is not considered material to the Company's condensed consolidated financial statements.     In determining fair value, the Company uses various valuation approaches within the fair value measurement framework. The valuation methodologies used for the Company’s instruments measured at fair value and their classification in the valuation hierarchy are summarized below: •Money market funds – Investments in money market funds are classified within Level 1. Money market funds are valued at the closing price reported by the fund sponsor from an actively traded exchange. At September 30, 2023 and December 31, 2022, money market funds were included as cash and cash equivalents in the condensed consolidated balance sheets. •Long-term marketable equity and debt securities – Investments in long-term marketable equity securities are classified within Level 1. The securities are recorded at fair value based on readily available quoted market prices in active markets. Investments in long-term marketable debt securities are classified within Level 2. The securities are recorded at fair value based on observable inputs for quoted prices for identical or similar assets in markets that are not active. Long-term marketable securities are located within other assets on the condensed consolidated balance sheets. •Contingent consideration – Contingent consideration is classified within Level 3. Contingent consideration relates to asset acquisitions and business combinations. The Company recorded the estimate of the fair value of the contingent consideration based on its evaluation of the probability of the achievement of the contractual conditions that would result in the payment of the contingent consideration. Contingent consideration was estimated using the fair value of the milestones to be paid if the contingency is met based on management’s estimate of the probability of success and projected revenues for revenue-based considerations at discounted rates ranging from 7% to 12% at September 30, 2023 and 12% at December 31, 2022. The significant input in the Level 3 measurement that is not supported by market activity is the Company’s probability assessment of the achievement of the milestones. The value of the liability is subsequently remeasured to fair value at each reporting date, and the change in estimated fair value is recorded as income or expense within operating expenses in the consolidated statements of operations until the milestones are paid, expire or are no longer achievable. Increases or decreases in the estimation of the probability percentage result in a directionally similar impact to the fair value measurement of the contingent consideration liability. The carrying amount of the contingent consideration liability represents its fair value. •Common stock warrant liability – Common stock warrant liability is classified within Level 3. The Company utilizes intrinsic value to estimate the fair value of the warrants. The intrinsic value is computed as the difference between the fair value of the Company’s common stock on the valuation date and the exercise price of the warrants. Increases (decreases) in the Company’s stock price discussed above result in a directionally similar impact to the fair value of the common stock warrant liability.

v3.23.3

Cash and Marketable Securities	9 Months Ended
	Sep. 30, 2023
Cash and Cash Equivalents [Abstract]
Cash and Marketable Securities	CASH AND MARKETABLE SECURITIES Cash, Cash Equivalents and Restricted Cash A reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the amount reported within the condensed consolidated statements of cash flows is shown in the table below (in thousands): September 30, 2023 September 30, 2022 Cash and cash equivalents $ 75,980  $ 82,959  Restricted cash 582  198  Total cash, cash equivalents and restricted cash at the end of the period $ 76,562  $ 83,157  Marketable Securities All short-term marketable securities were considered held-to-maturity at September 30, 2023. At September 30, 2023, some of the Company’s short-term marketable securities were in an unrealized loss position. The Company determined that it had the positive intent and ability to hold until maturity all short-term marketable securities that have been in a continuous loss position, thus there was no recognition of any other-than-temporary impairment as of September 30, 2023. All short-term marketable securities with unrealized losses as of the balance sheet date have been in a loss position for less than twelve months. Contractual maturities of the short-term marketable securities were within one year or less. The long-term marketable equity securities were recorded at fair market value with changes in the fair value recognized in earnings at September 30, 2023 and December 31, 2022. The long-term marketable debt securities were considered available-for-sale at September 30, 2023 and December 31, 2022. The contractual maturities of the long-term marketable debt securities are between one and three years. The amortized cost, gross unrealized holding gains (losses) and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands): September 30, 2023 Amortized Cost Unrealized Holding Gains (Losses) Fair Value Short-term marketable securities: U.S. agency securities $ 100,306  $ 1,991  $ 102,297  Corporate debt securities 91,898  584  92,482  Total short-term marketable securities 192,204  2,575  194,779  Long-term marketable securities: Corporate equity securities 5,100  (4,108) 992  Total long-term marketable securities 5,100  (4,108) 992  Total $ 197,304  $ (1,533) $ 195,771  December 31, 2022 Amortized Cost Unrealized Holding Gains (Losses) Fair Value Short-term marketable securities: U.S. agency securities $ 79,347  $ 452  $ 79,799  Corporate debt securities 123,821  (220) 123,601  Total short-term marketable securities 203,168  232  203,400  Long-term marketable securities: Corporate equity securities 5,000  (2,924) 2,076  Total long-term marketable securities 5,000  (2,924) 2,076  Total $ 208,168  $ (2,692) $ 205,476

v3.23.3

Business Combinations And Asset Acquisition	9 Months Ended
	Sep. 30, 2023
Business Combination and Asset Acquisition [Abstract]
Business Combination And Asset Acquisitions	BUSINESS COMBINATIONS AND ASSET ACQUISITION Business Combinations HLA Data Systems In January 2023, the Company acquired HLA Data Systems, a Texas-based company that provides software and interoperability solutions for the histocompatibility and immunogenetics community. The Company acquired HLA Data Systems with a combination of cash consideration paid upfront and contingent consideration with a fair value of $1.3 million. The Company accounted for the transaction as a business combination using the acquisition method of accounting. Acquisition-related costs of $0.4 million associated with the acquisition were expensed as incurred, and classified as part of general and administrative expenses in the condensed consolidated statement of operations. Goodwill of $2.1 million arising from the acquisition primarily consists of synergies from integrating HLA Data Systems’ technology with the current testing and digital solutions offered by the Company. The acquisition of HLA Data Systems will provide a robust and comprehensive Laboratory Information Management System and support the laboratory workflows. None of the goodwill is expected to be deductible for income tax purposes. All of the goodwill has been assigned to the Company’s existing operating segment. The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands): Estimated Fair Value Estimated Useful Lives (Years) Customer relationships $ 3,010  13 Developed technology 770  11 Trademarks 320  17 Total $ 4,100  Customer relationships acquired by the Company represent the fair value of future projected revenue that is expected to be derived from sales of HLA Data Systems’ products to existing customers. The customer relationships’ fair value has been estimated utilizing a multi-period excess earnings method under the income approach, which reflects the present value of the projected cash flows that are expected to be generated by the customer relationships, less charges representing the contribution of other assets to those cash flows that use projected cash flows with and without the intangible asset in place. The economic useful life was determined based on the distribution of the present value of the cash flows attributable to the intangible asset. The acquired developed technology represents the fair value of HLA Data Systems’ proprietary software. The trademark acquired consists primarily of the HLA Data Systems brand and markings. The fair value of both the developed technology and the trademark were determined using the relief-from-royalty method under the income approach. This method considers the value of the asset to be the value of the royalty payments from which the Company is relieved due to its ownership of the asset. The royalty rates of 10% and 2% were used to estimate the fair value of the developed technology and the trademark, respectively. A discount rate of 24% was utilized in estimating the fair value of these three intangible assets. The pro forma impact of the HLA Data Systems acquisition is not material, and the results of operations of the acquisition have been included in the Company’s condensed consolidated statements of operations from the respective acquisition date. MediGO In July 2023, the Company acquired MediGO, an organ transplant supply chain and logistics company. MediGO provides access to donated organs by digitally transforming donation and transplantation workflows to increase organ utilization. The Company acquired MediGO with a combination of cash consideration paid upfront and contingent consideration with a fair value of $0.3 million. The Company accounted for the transaction as a business combination using the acquisition method of accounting. Acquisition-related costs of $0.3 million associated with the acquisition were expensed as incurred, and classified as part of general and administrative expenses in the condensed consolidated statement of operations. Goodwill of $0.6 million arising from the acquisition primarily consists of synergies from integrating MediGO’s technology with the current testing and digital solutions offered by the Company. The acquisition of MediGO will provide a comprehensive software platform that optimizes complex logistics from referral to recovery and during the critical movement of organs and teams and gives organ procurement organizations and transplant centers the ability to unify decentralized stakeholders, coordinate resources and make vital decisions with the goal of increasing organ utilization and improving equity and access to transplantation. None of the goodwill is expected to be deductible for income tax purposes. All of the goodwill has been assigned to the Company’s existing operating segment. The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands): Estimated Fair Value Estimated Useful Lives (Years) Customer relationships $ 810  17 Developed technology 850  12 Trademarks 360  17 Total $ 2,020  Customer relationships acquired by the Company represent the fair value of future projected revenue that is expected to be derived from sales of MediGO’s products to existing customers. The customer relationships’ fair value has been estimated utilizing a multi-period excess earnings method under the income approach, which reflects the present value of the projected cash flows that are expected to be generated by the customer relationships, less charges representing the contribution of other assets to those cash flows that use projected cash flows with and without the intangible asset in place. The economic useful life was determined based on the distribution of the present value of the cash flows attributable to the intangible asset. The acquired developed technology represents the fair value of MediGO’s proprietary software. The trademark acquired consists primarily of the MediGO brand and markings. The fair value of both the developed technology and the trademark were determined using the relief-from-royalty method under the income approach. This method considers the value of the asset to be the value of the royalty payments from which the Company is relieved due to its ownership of the asset. The royalty rates of 10% and 2% were used to estimate the fair value of the developed technology and the trademark, respectively. A discount rate of 25% was utilized in estimating the fair value of these three intangible assets. The pro forma impact of the MediGO acquisition is not material, and the results of operations of the acquisition have been included in the Company’s condensed consolidated statements of operations from the respective acquisition date. Combined Consideration Paid The following table summarizes the consideration paid for HLA Data Systems and MediGO and the provisional amounts of the assets acquired and liabilities assumed recognized at their estimated fair value at the acquisition date (in thousands): Total Consideration Cash $ 6,682  Total consideration $ 6,682  Recognized amounts of identifiable assets acquired and liabilities assumed Current assets $ 1,413  Identifiable intangible assets 6,120  Current liabilities (1,060) Other current liabilities (810) Contingent considerations (1,620) Other liabilities (7) Total identifiable net assets acquired 4,036  Goodwill 2,646  Total consideration $ 6,682  The preliminary allocation of the purchase price to assets acquired and liabilities assumed was based on the fair value of such assets and liabilities as of the acquisition date. Asset Acquisition Effective as of August 9, 2023, the Company purchased an asset from a private entity. The asset consists of a licensing agreement with a university institution. See also Note 9. The purchased asset did not meet the definition of a business under ASC Topic 805, Business Combinations, and therefore the Company accounted for the transaction as an asset acquisition. In an asset acquisition, goodwill is not recognized, but rather, any excess consideration transferred over the fair value of the net assets acquired is allocated on a relative fair value basis to the identifiable assets acquired.Acquisition costs relating to the asset acquired were $2.6 million, comprised of base consideration of $1.8 million, contingent consideration at fair value of $0.5 million and associated transaction costs of $0.3 million. There was only one asset acquired and the entire cost is assigned to the licensing agreement, which is recorded under Intangible assets, net, in the condensed consolidated balance sheets and under the intangible assets with indefinite lives category.

v3.23.3

Goodwill and Intangible Assets	9 Months Ended
	Sep. 30, 2023
Goodwill and Intangible Assets Disclosure [Abstract]
Goodwill and Intangible Assets	GOODWILL AND INTANGIBLE ASSETS Goodwill Goodwill is recorded when the purchase price of an acquisition exceeds the fair value of the net tangible and identified intangible assets acquired. Goodwill is tested annually for impairment at the reporting unit level during the fourth quarter or upon the occurrence of certain events or substantive changes in circumstances. The Company identified an indicator of goodwill impairment in the three and nine months ended September 30, 2023. The balance of the Company’s goodwill was $40.2 million as of September 30, 2023 and $37.5 million as of December 31, 2022. Goodwill Impairment The Company assessed the current and future economic outlook as of September 30, 2023 for its single reporting unit and the Company experienced a sustained decrease in its share price, an indicator for impairment of goodwill. The evaluation began with a qualitative assessment to determine if it was more likely than not that the fair value of the reporting unit was less than its carrying value. The qualitative assessment did not indicate that it was more likely than not that the fair value exceeded the carrying value, which led to a quantitative assessment. The Company estimated the fair value of its reporting unit using a combination of the income and market approaches. In performing the goodwill impairment test, the Company used an exit multiple given the development phase of the Company and a discount rate of 16.4% in its estimation of fair value. The evaluation performed resulted in no impairment as of September 30, 2023. Intangible Assets The following table presents details of the Company’s intangible assets as of September 30, 2023 ($ in thousands): September 30, 2023 Gross Carrying Amount Accumulated Amortization Foreign Currency Translation Net Carrying Amount Weighted Average Remaining Useful Life (In Years) Intangible assets with finite lives: Acquired and developed technology $ 37,367  $ (17,529) $ (2,560) $ 17,278  7.4 Customer relationships 25,718  (8,663) (2,334) 14,721  9.5 Commercialization rights 11,578  (4,180) —  7,398  5.8 Trademarks and tradenames 5,220  (1,617) (356) 3,247  9.6 Total intangible assets with finite lives 79,883  (31,989) (5,250) 42,644  Intangible assets with indefinite lives: Acquired in-process technology 1,250  —  —  1,250  Favorable license agreement 2,561  —  —  2,561  Total intangible assets with indefinite lives 3,811  —  —  3,811  Total intangible assets $ 83,694  $ (31,989) $ (5,250) $ 46,455  The following table presents details of the Company’s intangible assets as of December 31, 2022 ($ in thousands): December 31, 2022 Gross Carrying Amount Accumulated Amortization Foreign Currency Translation Net Carrying Amount Weighted Average Remaining Useful Life (In Years) Intangible assets with finite lives: Acquired and developed technology $ 35,747  $ (15,138) $ (2,369) $ 18,240  7.5 Customer relationships 21,898  (7,459) (2,104) 12,335  9.0 Commercialization rights 11,579  (3,233) —  8,346  6.6 Trademarks and tradenames 4,540  (1,345) (315) 2,880  8.5 Total intangible assets with finite lives 73,764  (27,175) (4,788) 41,801  Acquired in-process technology 1,250  —  —  1,250  Total intangible assets $ 75,014  $ (27,175) $ (4,788) $ 43,051  Acquisition of Intangible Assets In January 2023 and July 2023, the Company acquired the intangible assets of HLA Data Systems and MediGO, respectively. The intangible assets are included in Acquired and developed technology, Customer relationships and Trademarks and tradenames as of September 30, 2023. Amortization of Intangible Assets Intangible assets are carried at cost less accumulated amortization. Amortization expenses are recorded to cost of testing services, cost of product, cost of patient and digital solutions, and sales and marketing expenses in the condensed consolidated statements of operations. The following table summarizes the Company’s amortization expense of intangible assets (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Cost of testing services $ 329  $ 329  $ 987  $ 987  Cost of product 408  415  1,242  1,305  Cost of patient and digital solutions 265  237  768  709  Sales and marketing 616  554  1,817  1,702  Total $ 1,618  $ 1,535  $ 4,814  $ 4,703  The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of September 30, 2023 (in thousands): Years Ending December 31, Cost of Testing Services Cost of Product Cost of Patient and Digital Solutions Sales and Marketing Total Remainder of 2023 $ 329  $ 405  $ 271  $ 634  $ 1,639  2024 1,316  1,621  850  2,494  6,281  2025 1,316  1,621  681  2,494  6,112  2026 1,316  732  681  2,492  5,221  2027 1,316  732  681  2,478  5,207  Thereafter 2,825  3,260  2,142  9,957  18,184  Total future amortization expense $ 8,418  $ 8,371  $ 5,306  $ 20,549  $ 42,644

v3.23.3

Balance Sheet Components	9 Months Ended
	Sep. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Balance Sheet Components	BALANCE SHEET COMPONENTS Inventory Inventory consisted of the following (in thousands): September 30, 2023 December 31, 2022 Finished goods $ 3,173  $ 2,962  Work in progress 4,939  4,306  Raw materials 9,866  11,964  Total inventory $ 17,978  $ 19,232  Accrued and Other Liabilities Accrued and other liabilities consisted of the following (in thousands): September 30, 2023 December 31, 2022 Clinical studies $ 14,677  $ 14,816  Professional fees 11,134  6,115  Short-term lease liability 5,958  5,591  Deferred revenue 5,766  5,342  Laboratory processing fees and materials 2,241  2,189  Contingent consideration 2,083  1,025  Accrued royalty 1,793  4,633  Deferred payments for intangible assets 920  2,062  Accrued shipping expenses 370  489  License and other collaboration fees 212  1,000  Capital expenditures —  1,316  Other accrued expenses 1,884  4,553  Total accrued and other liabilities $ 47,038  $ 49,131

v3.23.3

Commitments and Contingencies	9 Months Ended
	Sep. 30, 2023
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	COMMITMENTS AND CONTINGENCIES Leases The Company leases its operating and office facilities for various terms under long-term, non-cancelable operating lease agreements in Brisbane, California; Columbus, Ohio; West Chester, Pennsylvania; Flowood, Mississippi; Gaithersburg, Maryland; Fremantle, Australia; and Stockholm, Sweden.  The Company’s facility leases expire at various dates through 2033. In the normal course of business, it is expected that these leases will be renewed or replaced by leases on other properties. As of September 30, 2023, the carrying value of the ROU asset was $31.0 million. The related current and non-current liabilities as of September 30, 2023 were $6.0 million and $29.3 million, respectively. The current and non-current lease liabilities are included in accrued and other current liabilities and operating lease liability, less current portion, respectively, in the condensed consolidated balance sheets. The following table summarizes the lease cost for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Operating lease cost $ 1,981  $ 1,955  $ 5,936  $ 4,740  Total lease cost $ 1,981  $ 1,955  $ 5,936  $ 4,740  September 30, 2023 December 31, 2022 Other information: Weighted-average remaining lease term (in years) 5.63 6.26 Weighted-average discount rate (%) 7.1  % 7.1  % In February and June 2022, the Company entered into various lease agreements to lease office buildings in California, Nebraska and Australia with lease terms ranging from 2 to 10.5 years. Certain leases have options to renew the respective lease terms ranging from 5 to 10 years. In June 2022, the Company modified the termination date of the lease agreement for its former headquarters in South San Francisco, California from December 31, 2022 to July 15, 2022. As a result, the Company remeasured its lease liability using the current incremental borrowing rate and made an adjustment by reducing the ROU asset and lease liability by $0.5 million. Lease liabilities for the lease agreements made in February and June 2022 are recognized at the present value of the fixed lease payments using the current incremental borrowing rate at the lease commencement date. ROU assets are recognized based on the initial present value of the fixed lease payments. The following table summarizes the ROU assets and lease liabilities for certain lease agreements which commenced in July 2022 (in thousands): September 30, 2023 December 31, 2022 ROU assets $ 12,897  $ 14,321  Lease liabilities $ 13,915  $ 15,302  The following table summarizes the ROU assets and lease liabilities for certain lease agreements which commenced in August 2022 (in thousands): September 30, 2023 December 31, 2022 ROU assets $ 5,465  $ 5,814  Lease liabilities $ 5,732  $ 6,005  Maturities of operating lease liabilities as of September 30, 2023 are as follows (in thousands): Years Ending December 31, Operating Leases Remainder of 2023 $ 2,024  2024 7,955  2025 7,706  2026 7,019  2027 7,166  Thereafter 10,604  Total lease payments 42,474  Less imputed interest 7,264  Present value of future minimum lease payments 35,210  Less operating lease liability, current portion 5,958  Operating lease liability, long-term portion $ 29,252  The following table summarizes the supplemental cash flow information related to leases for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows used for operating leases $ 1,172  $ 822  $ 3,871  $ 2,746  Royalty Commitments The Board of Trustees of the Leland Stanford Junior University (“Stanford”) In June 2014, the Company entered into a license agreement with Stanford (the “Stanford License”), which granted the Company an exclusive license to a patent relating to the diagnosis of rejection in organ transplant recipients using dd-cfDNA. Under the terms of the Stanford License, the Company is required to pay an annual license maintenance fee, six milestone payments and royalties in the low single digits of net sales of products incorporating the licensed technology. In March 2023, the Stanford License agreement was amended, which reduced the maximum royalty rate to a lower rate at which the Company may be liable to Stanford effective from April 2022 and also provided that the Company would seek a review from the U.S. Supreme Court (the “Review”). During the pendency of the Review, certain of the Company’s licensing payment and reporting obligations to Stanford with respect to licensed products sold in the U.S. were suspended. As a result, the Company reversed the excess liability in March 2023. In May 2023, the Company submitted a petition of certiorari to the U.S. Supreme Court for consideration of the patent infringement suit and in October 2023, the U.S. Supreme Court declined to hear this patent infringement suit. As the Review is complete and our petition for review was denied, the Stanford License automatically terminated, and the Company will be required to pay to Stanford certain past royalties at a reduced rate that were previously suspended within 90 days of the termination. Illumina On May 4, 2018, the Company entered into a license agreement with Illumina, Inc. (the “Illumina Agreement”). The Illumina Agreement requires the Company to pay royalties in the mid-single to low double digits on sales of products covered by the Illumina Agreement. Other Royalty Commitment Effective as of August 9, 2023, the Company entered into a license agreement with a university institution (the "University Agreement"). The University Agreement requires the Company to pay royalties in the low single digits on sales of products covered by the University Agreement. Cibiltech Commitments Pursuant to that certain license and commercialization agreement that the Company entered into with Cibiltech, effective April 30, 2019, the Company will share an agreed-upon percentage of revenue with Cibiltech, if and when revenues are generated from iBox. In July 2023, the Company entered into a settlement agreement with Cibiltech (the “Settlement Agreement”), pursuant to which the Company agreed to pay a certain amount of its obligation owed to Cibiltech. A judicial court in Paris, France, granted the liquidation of Cibiltech, which filed for bankruptcy. In the Settlement Agreement, Cibiltech irrevocably waived and relinquished any and all claims, demands, grievances, proceeding, actions or other requests, whether judicial, administrative, arbitral or otherwise, against the Company. The outstanding obligation of the Company with Cibiltech was waived and relinquished, except for $0.4 million, which was paid in July 2023, and represented the amount that the Company agreed to per the Settlement Agreement. There is no outstanding obligation as of September 30, 2023. Other Commitments Pursuant to the Illumina Agreement, the Company has agreed to minimum purchase commitments of finished products and raw materials from Illumina, Inc. through 2023. Litigation and Indemnification Obligations In response to the Company’s false advertising suit filed against Natera Inc. (“Natera”) on April 10, 2019, Natera filed a counterclaim against the Company on February 18, 2020, in the U.S. District Court for the District of Delaware (the “Court”) alleging the Company made false and misleading claims about the performance capabilities of AlloSure. The suit seeks injunctive relief and unspecified monetary relief. On September 30, 2020, Natera requested leave of Court to amend its counterclaims to include additional allegations regarding purportedly false claims the Company made with respect to AlloSure, and the Court granted Natera’s request. The trial commenced on March 7, 2022 and concluded on March 14, 2022, with the jury finding that Natera violated the Lanham Act by falsely advertising the scientific performance of its Prospera transplant test and awarding the Company $44.9 million in damages, comprised of $21.2 million in compensatory damages and $23.7 million in punitive damages. In July 2023, the Court upheld and reaffirmed the March 2022 jury verdict but did not uphold the monetary damages awarded by the jury, which the Company intends to appeal. In August 2023, the Court issued an injunction prohibiting Natera from making the claims the jury previously found to be false advertising. The case is now on appeal. On July 19, 2022, the U.S. Court of Appeals for the Federal Circuit affirmed the Court’s judgment dismissing the Company’s patent infringement suit against Natera. In May 2023, the Company submitted a petition of certiorari to the U.S. Supreme Court for consideration of the patent infringement suit and in October 2023, the U.S. Supreme Court declined to hear the suit. In addition, Natera filed suit against the Company on January 13, 2020, in the Court alleging, among other things, that AlloSure infringes Natera’s U.S. Patent 10,526,658. This case was consolidated with the Company’s patent infringement suit on February 4, 2020. On March 25, 2020, Natera filed an amendment to the suit alleging, among other things, that AlloSure also infringes Natera’s U.S. Patent 10,597,724. The suit seeks a judgment that the Company has infringed Natera’s patents, an order preliminarily and permanently enjoining the Company from any further infringement of such patents and unspecified damages. On May 13, 2022, Natera filed two new complaints alleging that AlloSure infringes Natera’s U.S. Patents 10,655,180 and 11,111,544. These two cases were consolidated with the patent infringement case on June 15, 2022. On May 17, 2022, Natera agreed to dismiss the case alleging infringement of Natera’s U.S. Patent 10,526,658. On July 6, 2022, the Company moved to dismiss the rest of Natera’s claims. On September 6, 2022, the Company withdrew its motion to dismiss. The case is ongoing. The Company intends to defend both of these matters vigorously, and believes that the Company has good and substantial defenses to the claims alleged in the suits, but there is no guarantee that the Company will prevail. The Company has not recorded any liabilities for these suits. United States Department of Justice and United States Securities and Exchange Commission Investigations As previously disclosed, in 2021, the Company received a civil investigative demand (“CID”) from the United States Department of Justice (“DOJ”) requesting that the Company produce certain documents in connection with a False Claims Act investigation being conducted by the DOJ regarding certain business practices related to the Company’s kidney testing and phlebotomy services, and a subpoena from the United States Securities and Exchange Commission (the “SEC”) in relation to an investigation by the SEC in respect of matters similar to those identified in the CID, as well as certain of the Company’s accounting and public reporting practices. By letter dated September 19, 2023, the Company was notified by the staff of the SEC that the SEC has concluded its investigation as to the Company and does not intend to recommend an enforcement action by the SEC against the Company. The notice was provided under the guidelines set out in the final paragraph of Securities Act Release No. 5310. The Company may receive additional requests for information from the DOJ, the SEC, or other regulatory and governmental agencies regarding similar or related subject matters. The Company does not believe that the CID raises any issues regarding the safety or efficacy of any of the Company’s products or services and are cooperating fully with the DOJ investigation. Although the Company remains committed to compliance with all applicable laws and regulations, it cannot predict the outcome of the DOJ investigation or any other requests or investigations that may arise in the future regarding these or other subject matters. From time to time, the Company may become involved in litigation and other legal actions. The Company estimates the range of liability related to any pending litigation where the amount and range of loss can be estimated. The Company records its best estimate of a loss when the loss is considered probable. Where a liability is probable and there is a range of estimated loss with no best estimate in the range, the Company records a charge equal to at least the minimum estimated liability for a loss contingency when both of the following conditions are met: (i) information available prior to issuance of the condensed consolidated financial statements indicates that it is probable that a liability had been incurred at the date of the condensed consolidated financial statements, and (ii) the range of loss can be reasonably estimated. Olymbios Matter On April 15, 2022, a complaint was filed by Michael Olymbios against the Company in the Superior Court of the State of California for the County of San Mateo (the “San Mateo County Court”). The complaint alleges that the Company failed to pay certain fees and costs required to continue an arbitration proceeding against Dr. Olymbios, and that the Company has defamed Dr. Olymbios. Dr. Olymbios also seeks to void restrictive covenants previously agreed to by him in favor of the Company and to recover damages purportedly incurred by Dr. Olymbios. The Company filed a motion to compel arbitration and dismiss the case. On April 25, 2022, the San Mateo County Court granted the Company’s ex parte application to stay the case and advance the hearing date to June 10, 2022 for the motion to compel arbitration and dismiss. At the June 10, 2022 hearing, the San Mateo County Court found that the decision should be made by the arbitrator, and stayed the case. On July 19, 2022, Dr. Olymbios filed a motion to withdraw from arbitration before Judicial Arbitration and Mediation Services, Inc., which was denied on August 18, 2022. The matter is currently proceeding in arbitration. The Company intends to vigorously pursue its arbitration proceeding against Dr. Olymbios and to vigorously defend itself against Dr. Olymbios’ claims. The Company believes it has good and substantial support for its claims and good and substantial defenses to the claims alleged in the suit by Dr. Olymbios, but there is no guarantee that the Company will prevail if the case continues. The Company has not recorded any liabilities for this suit. Securities Class Action On May 23, 2022, Plumbers & Pipefitters Local Union #295 Pension Fund filed a federal securities class action in the U.S. District Court for the Northern District of California against the Company, Reginald Seeto, its former President, Chief Executive Officer and member of the Company’s Board of Directors, Ankur Dhingra, its former Chief Financial Officer, Marcel Konrad, its former interim Chief Financial Officer and former Senior Vice President of Finance & Accounting, and Peter Maag, its former President, former Chief Executive Officer, former Chairman of the Company’s Board of Directors and current member of the Company’s Board of Directors. The action alleges that the Company and the individual defendants made materially false and/or misleading statements and/or omissions and that such statements violated Section 10(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Rule 10b-5 promulgated thereunder. The action also alleges that the individual defendants are liable pursuant to Section 20(a) of the Exchange Act as controlling persons of the Company. The suit seeks to recover damages caused by the alleged violations of federal securities laws, along with the plaintiffs’ costs incurred in the lawsuit, including their reasonable attorneys’ and experts’ witness fees and other costs. On August 25, 2022, the court appointed an investor group led by the Oklahoma Police Pension and Retirement System as lead plaintiffs and appointed Saxena White P.A. and Robbins Geller Rudman & Dowd LLP as lead counsels. Plaintiffs filed an amended complaint on November 28, 2022. On January 27, 2023, defendants moved to dismiss all claims and to strike certain allegations in the amended complaint. On May 24, 2023, the court granted the Company’s motion to strike and motion to dismiss, dismissing all claims against defendants with leave to amend. On June 28, 2023, plaintiffs filed a second amended complaint against the Company, Reginald Seeto, Ankur Dhingra, and Peter Maag. Under a briefing schedule ordered by the court on June 12, 2023, defendants’ motion to dismiss and motion to strike the second amended complaint was filed on July 26, 2023, plaintiffs’ opposition was filed on August 30, 2023, and defendants’ reply was filed on September 22, 2023. The court held oral argument on October 31, 2023. The Company intends to defend itself vigorously, and believes that the Company has good and substantial defenses to the claims alleged in the suit, but there is no guarantee that the Company will prevail. The Company has not recorded any liabilities for this suit. Derivative Actions On September 21, 2022, Jeffrey Edelman brought a stockholder derivative action complaint in the U.S. District Court for the Northern District of California against the Company as nominal defendant and Drs. Seeto and Maag and Mr. Dhingra, and other current and former members of the Company’s Board of Directors (the “Edelman Derivative Action”). The plaintiff alleges that the individual defendants breached their fiduciary duties as directors and/or officers of the Company and engaged in insider trading, waste of corporate assets, unjust enrichment and violations of Sections 14(a) and 20(a) of the Exchange Act. The action alleges that the individual defendants are liable pursuant to Section 20(a) of the Exchange Act as controlling persons of the Company. The suit seeks a declaration that the individual defendants breached their fiduciary duties to the Company, violated Sections 14(a) and 20(a) of the Exchange Act and were unjustly enriched, and also seeks to recover damages sustained by the Company as a result of the alleged violations, along with the plaintiff’s costs incurred in the lawsuit, including reasonable attorneys’ and experts’ fees, costs and expenses. On December 8, 2022, the court stayed the Edelman Derivative Action until 20 days after the earlier of the following events: (a) the securities class action is dismissed in its entirety with prejudice; (b) the motion to dismiss in the securities class action is denied; (c) a joint request by plaintiff and defendants to lift the stay; (d) notification that a related derivative action that has been filed is not stayed or is no longer stayed; or (e) notification that there has been a settlement reached in the securities class action or any related derivative action. On February 7, 2023, Jaysen Stevenson brought a stockholder derivative action complaint in the U.S. District Court for the Northern District of California against the Company as nominal defendant and Drs. Seeto and Maag and Mr. Dhingra and other current and former members of the Company’s Board of Directors (the “Stevenson Derivative Action”). The claims and allegations in the Stevenson Derivative Action are substantially similar to those in the Edelman Derivative Action. The plaintiff alleges that the individual defendants breached their fiduciary duties as directors and/or officers of the Company and engaged in insider trading, waste of corporate assets, unjust enrichment and violations of Sections 14(a) and 20(a) of the Exchange Act. The suit seeks declaratory relief and to recover alleged damages sustained by the Company as a result of the alleged violations, along with the plaintiff’s costs incurred in the lawsuit, including reasonable attorneys’ and experts’ fees, costs and expenses. On March 9, 2023, the court consolidated the Edelman Derivative Action and the Stevenson Derivative Action and stayed both actions pursuant to the terms of the stay order in the Edelman Derivative Action. The consolidated derivative action remains stayed. The parties in the Stevenson Derivative Action filed a joint status statement with the court on September 6, 2023. The Company intends to defend itself vigorously, and believes that the Company has good and substantial defenses to the claims alleged in the suits, but there are no guarantees that the Company will prevail. Insurance Matter In December 2022, the Company filed a lawsuit against its Directors and Officers liability insurance carriers in San Mateo County Superior Court. The Company seeks a declaration that costs and fees incurred by the Company in responding to governmental investigatory requests are covered under its policies. The Company also asserts breach of contract against its primary insurer Great American Insurance Company for denying the claim. The policies provide up to $15 million in coverage limits. The Company intends to vigorously pursue its claims, and believes it has good and substantial support for its claims, but there is no guarantee that the Company will prevail in these claims.

v3.23.3

401(K) Plan	9 Months Ended
	Sep. 30, 2023
Retirement Benefits [Abstract]
401(K) Plan	401(K) PLANThe Company sponsors a 401(k) defined contribution plan (the “401(k) Plan”) covering all U.S. employees under the Internal Revenue Code of 1986, as amended. Employee contributions to the 401(k) Plan are voluntary and are determined on an individual basis subject to the maximum allowable under federal tax regulations. The Company incurred expenses related to contributions to the 401(k) Plan of $0.2 million and $0.3 million for the three months ended September 30, 2023 and 2022, respectively. The Company incurred expenses related to contributions to the 401(k) Plan of $1.4 million and $1.5 million for the nine months ended September 30, 2023 and 2022, respectively.

v3.23.3

Warrants	9 Months Ended
	Sep. 30, 2023
Warrants and Rights Note Disclosure [Abstract]
Warrants	WARRANTS The Company issues common stock warrants in connection with debt or equity financings to lenders, placement agents and investors. Issued warrants are considered standalone financial instruments and the terms of each warrant are analyzed for equity or liability classification in accordance with U.S. GAAP. Warrants that are classified as liabilities usually have various features that would require net-cash settlement by the Company. Warrants that are not liabilities, derivatives and/or meet the exception criteria are classified as equity. Warrants liabilities are remeasured at fair value at each period end with changes in fair value recorded in the condensed consolidated statements of operations until expired or exercised. Warrants that are classified as equity are valued at their relative fair value on the date of issuance, recorded in additional paid in capital and not remeasured. In the three months ended September 30, 2023, no warrants to purchase shares of common stock were exercised. In the nine months ended September 30, 2023, warrants to purchase approximately 3,000 shares of common stock were exercised for cash proceeds of $4,000. In the three and nine months ended September 30, 2022, no warrants to purchase shares of common stock were exercised. As of September 30, 2023, no warrants to purchase common stock were outstanding.

v3.23.3

Stock Incentive Plans	9 Months Ended
	Sep. 30, 2023
Share-Based Payment Arrangement [Abstract]
Stock Incentive Plans	STOCK INCENTIVE PLANS Stock Options and Restricted Stock Units (“RSU”) The following table summarizes option and RSU activity under the Company’s 2014 Equity Incentive Plan, 2016 Inducement Equity Incentive Plan and 2019 Inducement Equity Incentive Plan, and related information: Shares Available for Grant Stock Options Outstanding Weighted- Average Exercise Price Number of RSU Shares Weighted- Average Grant Date Fair Value Balance—December 31, 2022 1,490,462  2,921,925  $ 28.13  3,094,396  $ 37.39  Additional shares authorized 2,141,330  —  —  —  —  Common stock awards for services (15,809) —  —  —  —  RSUs granted (3,461,674) —  —  3,461,674  11.11  RSUs vested —  —  —  (815,374) 35.90  Options granted (680,788) 680,788  12.60  —  —  Options exercised —  (23,203) 4.59  —  —  Repurchase of common stock under employee incentive plans 265,953  —  —  —  —  RSUs forfeited 761,771  —  —  (761,771) 24.67  Options forfeited 178,830  (178,830) 27.61  —  —  Options expired 236,645  (236,645) 26.93  —  —  Balance—September 30, 2023 916,720  3,164,035  $ 25.18  4,978,925  $ 21.24  The total intrinsic value of options exercised was $74,000 and $0.1 million for the three and nine months ended September 30, 2023, respectively. The total intrinsic value of options exercised was $0.1 million and $1.3 million for the three and nine months ended September 30, 2022, respectively. As of September 30, 2023, the total intrinsic value of outstanding RSUs was approximately $35.8 million and there were $63.6 million of unrecognized compensation costs related to RSUs, which are expected to be recognized over a weighted-average period of 2.51 years. Options outstanding that have vested and are expected to vest at September 30, 2023 are as follows: Number of Shares Issued (In thousands) Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life (Years) Aggregate Intrinsic Value (In thousands) Vested 1,620  $ 26.60  6.48 $ 399  Expected to vest 1,378  23.50  8.84 —  Total 2,998  $ 399  The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock options and the fair value of the Company’s common stock at September 30, 2023 for stock options that were in-the-money. The total fair value of options that vested during the three and nine months ended September 30, 2023 was $3.2 million and $15.6 million, respectively. As of September 30, 2023, there were approximately $20.4 million of unrecognized compensation costs related to stock options, which are expected to be recognized over a weighted-average period of 2.40 years. 2014 Employee Stock Purchase Plan The Company has an Employee Stock Purchase Plan (the “ESPP”), under which employees can purchase shares of its common stock based on a percentage of their compensation, but not greater than 15% of their respective earnings; provided, however, an eligible employee’s right to purchase shares of the Company’s common stock may not accrue at a rate which exceeds $25,000 of the fair market value of such shares for each calendar year in which such rights are outstanding. The ESPP has consecutive offering periods of approximately six months in length. The purchase price per share must be equal to the lower of 85% of the fair value of the common stock on the first day of the offering period or on the exercise date. During the offering period in 2023 that ended on June 30, 2023, 143,817 shares were purchased pursuant to the ESPP for aggregate proceeds of $1.0 million from the issuance of such shares, which occurred on July 6, 2023. During the offering period in 2022 that ended on December 31, 2022, 47,025 shares were purchased pursuant to the ESPP for aggregate proceeds of $0.5 million from the issuance of such shares, which occurred on January 2, 2023.   Valuation Assumptions The estimated fair values of employee stock options and ESPP shares were estimated using the Black-Scholes option pricing model based on the following weighted average assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Employee stock options Expected term (in years) N/A 6.0 5.6 6.0 Expected volatility N/A 78.29% 77.86% 77.58% Risk-free interest rate N/A 2.99% 3.67% 2.69% Expected dividend yield N/A —% —% —% Employee stock purchase plan Expected term (in years) 0.5 0.5 0.5 0.5 Expected volatility 93.38% 91.16% 93.38% 74.66% Risk-free interest rate 5.53% 3.92% 5.49% 2.92% Expected dividend yield —% —% —% —% Risk-free Interest Rate: The Company based the risk-free interest rate over the expected term of the award based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of grant. Volatility: The Company used an average historical stock price volatility of its own stock. Expected Term: The expected term represents the period for which the Company’s stock-based compensation awards are expected to be outstanding and is based on analyzing the vesting and contractual terms of the awards and the holders’ historical exercise patterns and termination behavior. Expected Dividends: The Company has not paid and does not anticipate paying any dividends in the near future. Stock-Based Compensation Expense The following table summarizes stock-based compensation expense relating to employee and non-employee stock-based awards for the three and nine months ended September 30, 2023 and 2022, included in the condensed consolidated statements of operations as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Cost of testing services $ 496  $ 470  $ 1,467  $ 1,055  Cost of product 301  321  935  851  Cost of patient and digital solutions 297  299  1,066  882  Research and development 1,491  2,058  5,157  6,571  Sales and marketing 3,041  2,672  9,557  9,702  General and administrative 7,045  5,380  20,943  15,366  Total $ 12,671  $ 11,200  $ 39,125  $ 34,427  No tax benefit was recognized related to stock-based compensation expense since the Company has never reported taxable income and has established a full valuation allowance to offset all of the potential tax benefits associated with its deferred tax assets. In addition, no amounts of stock-based compensation expense were capitalized for the periods presented.

v3.23.3

Income Taxes	9 Months Ended
	Sep. 30, 2023
Income Tax Disclosure [Abstract]
Income Taxes	INCOME TAXESThe Company's effective tax rate may vary from the U.S. federal statutory tax rate due to a change in valuation allowance, change in the mix of earnings in tax jurisdictions with different statutory rates, benefits related to tax credits, and the tax impact of non-deductible expenses and other permanent differences between income before income taxes and taxable income. The Company assesses the realizability of its net deferred tax assets by evaluating all available evidence, both positive and negative, including (i) cumulative results of operations in recent years, (ii) sources of recent losses, (iii) estimates of future taxable income, and (iv) the length of net operating loss carryforward periods. The Company believes that based on the history of its U.S. losses and other factors, the weight of available evidence indicates that it is more likely than not that it will not be able to realize its U.S. consolidated net deferred tax assets. Accordingly, the U.S. and Sweden net deferred tax assets have been offset by a full valuation allowance. For the three and nine months ended September 30, 2023, the Company recorded an income tax benefit of $80,000 and $24,000, respectively. For the three and nine months ended September 30, 2022, the Company recorded an income tax expense of $0.3 million and $0.2 million, respectively. The income tax benefit of $80,000 and $24,000 for the three and nine months ended September 30, 2023, respectively, is primarily attributable to the U.S. current tax benefit resulting from the recently filed 2022 income tax returns and a U.S. deferred tax benefit resulting from the acquisition of MediGO in July 2023.

v3.23.3

Segment Reporting	9 Months Ended
	Sep. 30, 2023
Segment Reporting [Abstract]
Segment Reporting	SEGMENT REPORTING Operating segments are defined as components of an enterprise for which separate financial information is available that is evaluated regularly by the Company’s Chief Operating Decision Maker (“CODM”), or decision making group, whose function is to allocate resources to and assess the performance of the operating segments. The Company has identified its Chief Executive Officer as the CODM. In determining its reportable segments, the Company considered the markets and types of customers served and the products or services provided in those markets. The Company operates in a single reportable segment. Revenues by geographic regions are based upon the customers’ ship-to address for product revenue and the region of testing for testing services revenue. The following table summarizes reportable revenues by geographic regions (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Testing services revenue United States $ 47,644  $ 64,547  $ 162,560  $ 197,675  Rest of World 140  204  422  655  $ 47,784  $ 64,751  $ 162,982  $ 198,330  Product revenue United States $ 5,810  $ 4,245  $ 13,857  $ 11,435  Europe 2,437  2,262  7,430  6,887  Rest of World 1,289  687  2,986  2,374  $ 9,536  $ 7,194  $ 24,273  $ 20,696  Patient and digital solutions revenue United States $ 9,735  $ 7,187  $ 27,130  $ 19,865  Europe 34  209  239  429  Rest of World 103  18  131  89  $ 9,872  $ 7,414  $ 27,500  $ 20,383  Total United States $ 63,189  $ 75,979  $ 203,547  $ 228,975  Total Europe $ 2,471  $ 2,471  $ 7,669  $ 7,316  Total Rest of World $ 1,532  $ 909  $ 3,539  $ 3,118  Total $ 67,192  $ 79,359  $ 214,755  $ 239,409  The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions (in thousands): September 30, 2023 December 31, 2022 Long-lived assets: United States $ 34,815  $ 35,020  Europe 471  405  Rest of World 69  104  Total $ 35,355  $ 35,529

v3.23.3

Restructuring	9 Months Ended
	Sep. 30, 2023
Restructuring and Related Activities [Abstract]
Restructuring	RESTRUCTURING In January 2023, the Company announced a restructuring plan that is intended to optimize costs and simplify its organizational and corporate structure. The restructuring plan includes the discontinuation of the Company’s operations in Fremantle, Australia, terminating its employees in that location and vacating its facilities there. The Company incurred immaterial restructuring charges for each of the three and nine months ended September 30, 2023. The Company expects to complete the closure of its Australia location in June 2024. In May 2023, the Company announced a reduction of its U.S. workforce to simplify and streamline its organization and strengthen the overall effectiveness of its operations. The restructuring charges are primarily related to employee severance pay and related costs. As a result of this plan, the Company incurred $0.8 million in restructuring charges for the three months ended June 30, 2023. The Company did not incur any restructuring charges related to this plan in the three months ended September 30, 2023.

v3.23.3

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2023	Sep. 30, 2022
Pay vs Performance Disclosure
Net loss	$ (23,485)	$ (24,953)	$ (23,749)	$ (16,939)	$ (21,697)	$ (19,648)	$ (72,187)	$ (58,284)

v3.23.3

Insider Trading Arrangements	3 Months Ended
	Sep. 30, 2023
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

v3.23.3

Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2023
Accounting Policies [Abstract]
Liquidity and Capital Resources	Liquidity and Capital Resources The Company has incurred significant losses and negative cash flows from operations since its inception and had an accumulated deficit of $534.2 million at September 30, 2023. As of September 30, 2023, the Company had cash, cash equivalents and marketable securities of $268.2 million and no debt outstanding.
Basis of Presentation	Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”), and follow the requirements of the SEC for interim reporting. As permitted under those rules, certain notes and other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of the Company’s financial information. The condensed consolidated balance sheet as of December 31, 2022 has been derived from audited consolidated financial statements as of that date but does not include all of the financial information required by U.S. GAAP for complete financial statements. Operating results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023.
Use of Estimates	Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the unaudited condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to transaction price estimates used for testing services revenue; standalone fair value of patient and digital solutions revenue performance obligations; accrued expenses for clinical studies; inventory valuation; the fair value of issued common stock warrants and embedded derivatives; the fair value of assets and liabilities acquired in a business combination or an assets acquisition (including identifiable intangible assets acquired); the fair value of contingent consideration recorded in connection with a business combination or an asset acquisition; the grant date fair value assumptions used to estimate stock-based compensation expense; income taxes; impairment of long-lived assets and indefinite-lived assets (including goodwill); and legal contingencies. Actual results could differ from those estimates.
Concentrations of Credit Risk and Other Risks and Uncertainties	Concentrations of Credit Risk and Other Risks and Uncertainties For the three months ended September 30, 2023 and 2022, approximately 36% and 53%, respectively, of total revenue was derived from Medicare. For the nine months ended September 30, 2023 and 2022, approximately 41% and 54%, respectively, of total revenue was derived from Medicare. As of September 30, 2023 and December 31, 2022, approximately 36% and 27%, respectively, of accounts receivable was due from Medicare. No other payer or customer represented more than 10% of accounts receivable at either September 30, 2023 or December 31, 2022.
Marketable Securities	Marketable Securities The Company considers all highly liquid investments in securities with a maturity of greater than three months at the time of purchase to be marketable securities. As of September 30, 2023, the Company’s short-term marketable securities consisted of corporate debt securities with maturities of greater than three months but less than twelve months at the time of purchase, which were classified as current assets on the condensed consolidated balance sheet. The Company classifies its short-term marketable securities as held-to-maturity at the time of purchase and reevaluates such designation at each balance sheet date. The Company has the positive intent and ability to hold these marketable securities to maturity. Short-term marketable securities are carried at amortized cost and are adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income (expense), net on the condensed consolidated statements of operations. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on short-term marketable securities are included in interest income (expense), net. The cost of securities sold will be determined using specific identification. The Company considers investments in securities with remaining maturities of over one year as long-term investments. As of September 30, 2023, the Company’s long-term marketable securities consisted of corporate equity securities and corporate debt securities. These long-term marketable securities are classified as other assets on the condensed consolidated balance sheet. The Company classifies its long-term marketable debt securities as available-for-sale and reevaluates such designation at each balance sheet date. Unrealized gains and losses from the reevaluation of the long-term marketable debt securities, if any, are included in other comprehensive gain (loss) in the condensed consolidated statement of comprehensive income (loss). Realized gains and losses and declines in value judged to be other-than-temporary, if any, on long-term marketable securities are included in interest income (expense), net. The Company records its long-term marketable equity securities at fair market value. Unrealized gains and losses from the remeasurement of the long-term marketable equity securities to fair value are included in other income (expense), net, in the condensed consolidated statements of operations.
Leases	Leases The Company adopted Accounting Standard Codification (“ASC”) Topic 842, Leases, and determines if an arrangement is or contains a lease at contract inception. A right-of-use (“ROU”) asset, representing the underlying asset during the lease term, and a lease liability, representing the payment obligation arising from the lease, are recognized on the condensed consolidated balance sheet at lease commencement based on the present value of the payment obligation. For operating leases, expense is recognized on a straight-line basis over the lease term. For finance leases, interest expense on the lease liability is recognized using the effective interest method and amortization of the ROU asset is recognized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. The Company also has lease arrangements with lease and non-lease components. The Company elected the practical expedient not to separate non-lease components from lease components for the Company’s facility leases. The Company also elected to apply the short-term lease measurement and recognition exemption in which ROU assets and lease liabilities are not recognized for leases with an initial term of 12 months or less. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment.
Revenue	Revenue The Company recognizes revenue from testing services, product sales and patient and digital solutions revenue in the amount that reflects the consideration that it expects to be entitled in exchange for goods or services as it transfers control to its customers. Revenue is recorded considering a five-step revenue recognition model that includes identifying the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price to the performance obligations and recognizing revenue when, or as, an entity satisfies a performance obligation. Testing Services Revenue AlloSure Kidney, AlloMap Heart, AlloSure Heart and AlloSure Lung patient tests are ordered by healthcare providers. The Company receives a test requisition form with payer information along with a collected patient blood sample. The Company considers the patient to be its customer and the test requisition form to be the contract. Testing services are performed in the Company’s laboratory. Testing services represent one performance obligation in a contract and are performed when results of the test are provided to the healthcare provider, at a point in time. The healthcare providers that order the tests and on whose behalf the Company provides testing services are generally not responsible for the payment of these services. The first and second revenue recognition criteria are satisfied when the Company receives a test requisition form with payer information from the healthcare provider. Generally, the Company bills third-party payers upon delivery of an AlloSure Kidney, AlloMap Heart, AlloSure Heart or AlloSure Lung test result to the healthcare provider. Amounts received may vary amongst payers based on coverage practices and policies of the payer. The Company has used the portfolio approach under ASC Topic 606, Revenue from Contracts with Customers, to identify financial classes of payers. Revenue recognized for Medicare and other contracted payers is based on the agreed current reimbursement rate per test, adjusted for historical collection trends where applicable. The Company estimates revenue for non-contracted payers and self-payers using transaction prices determined for each financial class of payers using history of reimbursements. This includes analysis of an average reimbursement per test and a percentage of tests reimbursed. This estimate requires significant judgment. The Company monitors revenue estimates at each reporting period based on actual cash collections in order to assess whether a revision to the estimate is required. Changes in transaction price estimates are updated quarterly based on actual cash collected or changes made to contracted rates. On March 2, 2023, MolDX issued a new Billing Article, with an effective date of March 31, 2023. The Billing Article impacts Medicare coverage for AlloSure Kidney, AlloSure Heart and AlloMap Heart and requires the Company to implement new processes to address requirements related to Medicare claim submissions. ASC 606-10-25-1 requires the Company to assess whether it is probable that it will collect substantially all of the consideration to which it will be entitled when determining if a contract with a customer exists. Based upon the Company’s review of the Billing Article, it was determined to pause Medicare reimbursement submissions for AlloSure Kidney commencing on March 7, 2023 that created uncertainty around the collection of the claims. Accordingly, the Company did not submit claims for approximately 3,200 AlloSure Kidney tests for Medicare reimbursement for the period from March 7, 2023 through March 31, 2023 and did not recognize revenue on these claims in the first quarter of 2023 aggregating to approximately $8.9 million. On May 18, 2023, the Company submitted a letter to Noridian explaining, among other things, (i) the Company’s belief that the Billing Articles imposed new restrictions on Medicare coverage for the CareDx tests from those contained in the existing LCDs, (ii) that the Company planned to submit claims for reimbursement for the Impacted March Tests for which the Company has not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing Articles, and (iii) that AlloSure Kidney orders with a date of service on or after March 31, 2023 for other indications outside the parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article. Following the submission of this letter to Noridian, on May 18, 2023, the Company submitted claims for reimbursement for the Impacted March Tests, for which the Company subsequently received payment from Noridian and recognized revenue totaling approximately $7.8 million in the second quarter of 2023. The Company has certain unbilled AlloSure Kidney claims with a service date after March 31, 2023, where the reason for testing is not specified by the ordering physician. The Company is in the process of supplementation for these tests. If these AlloSure Kidney tests are within the parameters of the Revised Billing Article, the Company will bill and would expect to recognize revenue in the quarter that the supplementation is completed. The Company continues its Medicare reimbursement submissions for AlloMap Heart or AlloSure Heart following the issuance of the Billing Articles. In addition, the Company informed Noridian on May 18, 2023 that until Noridian adopted the Revised Billing Article, the Company would continue to submit AlloSure Heart tests for reimbursement only when used in conjunction with AlloMap Heart. The Company also informed Noridian on May 18, 2023 that (i) until June 30, 2023, it planned to submit claims for reimbursement for AlloMap Heart and AlloSure Heart tests for which the Company has not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing Articles, and (ii) AlloSure Heart and AlloMap Heart orders placed on or after June 30, 2023 for other indications outside the surveillance and for-cause parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article. On August 28, 2023, the Company submitted a subsequent letter to Noridian regarding its AlloSure Heart and AlloMap Heart testing submissions, explaining, among other things, that (i) prior to August 17, 2023, the Company submitted claims as outlined in its prior communications, including submitting AlloSure Heart and AlloMap Heart claims that were in compliance with the billing article in effect for Noridian (but that were not necessarily in compliance with the Revised Billing Article that had not yet been adopted by Noridian); (ii) for claims with dates of service of August 17, 2023 or later, the Company is submitting AlloSure Heart and AlloMap Heart testing claims in compliance with the Revised Billing Article, including submitting AlloSure Heart claims when not used in conjunction with AlloMap Heart, and submitting HeartCare (AlloSure Heart and AlloMap Heart used together in a single patient encounter) claims for surveillance testing in lieu of a biopsy from 55 days to 370 days post-transplant; and (iii) for AlloSure Heart and AlloMap Heart tests performed on or after August 17, 2023 that are outside the parameters of the Revised Billing Article, certain billing codes will be used to enable any additional review deemed appropriate by Noridian and potential appeal by the Company of the denied claims. On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto; DL38629, Noridian) that, if adopted, would revise the existing foundational LCD, MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629). On August 14, 2023, MolDX released a draft billing article (DA58019) to accompany the proposed draft LCD, which generally reflected the changes in coverage included in the Revised Billing Article. The comment period end date for this proposed LCD was September 23, 2023. The Company presented at public meetings regarding the proposed draft LCD held on September 18, 2023 and September 20, 2023, with MolDX and Noridian, respectively. The Company also submitted written comments on the proposed draft LCD. Product Revenue Product revenue is recognized from the sale of products to end-users, distributors and strategic partners when all revenue recognition criteria are satisfied. The Company generally has a contract or a purchase order from a customer with the specified required terms of order, including the number of products ordered. Transaction prices are determinable and products are delivered and the risk of loss is passed to the customer upon either shipping or delivery, as per the terms of the agreement. Patient and Digital Solutions Revenue Patient and digital solutions revenue is mainly derived from a combination of software as a service (“SaaS”) and perpetual software license agreements entered into with various transplant centers, which are the Company’s customers for this class of revenue. The main performance obligations in connection with the Company’s SaaS and perpetual software license agreements are the following: (i) implementation services and delivery of the perpetual software license, which are considered a single performance obligation, and (ii) post contract support. The Company allocates the transaction price to each performance obligation based on relative stand-alone selling prices of each distinct performance obligation. Digital revenue in connection with perpetual software license agreements is recognized over time based on the Company’s satisfaction of each distinct performance obligation in each agreement. Perpetual software license agreements typically require advance payments from customers upon the achievement of certain milestones. The Company records deferred revenue in relation to these agreements when cash payments are received or invoices are issued in advance of the Company’s performance, and generally recognizes revenue over the contractual term, as performance obligations are fulfilled. In addition, the Company derives patient and digital solutions revenue from software subscriptions and medication sales. The Company generally bills software subscription fees in advance. Revenue from software subscriptions is deferred and recognized ratably over the subscription term. The medication sales revenue is recognized based on the negotiated contract price with the governmental, commercial and non-commercial payers with any applicable patient co-pay. The Company recognizes revenue from medication sales when prescriptions are delivered.
Recent Accounting Pronouncements	Recent Accounting PronouncementsThere were no recently adopted accounting standards which would have a material effect on the Company’s condensed consolidated financial statements and accompanying disclosures, and no recently issued accounting standards that are expected to have a material impact on the Company’s condensed consolidated financial statements and accompanying disclosures.

v3.23.3

Net Loss Per Share (Tables)	9 Months Ended
	Sep. 30, 2023
Earnings Per Share [Abstract]
Summary of Computation of Basic and Diluted Net Loss Per Share	The following tables set forth the computation of the Company’s basic and diluted net loss per share (in thousands, except shares and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net loss used to compute basic and diluted net loss per share $ (23,485) $ (16,939) $ (72,187) $ (58,284) Denominator: Weighted-average shares used to compute basic and diluted net loss per share 54,178,759  53,489,418  53,891,374  53,253,210  Net loss per share: Basic and diluted $ (0.43) $ (0.32) $ (1.34) $ (1.09)
Summary of Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share	The following potentially dilutive securities have been excluded from diluted net loss per share as of September 30, 2023 and 2022 because their effect would be antidilutive: Three and Nine Months Ended September 30, 2023 2022 Shares of common stock subject to outstanding options 3,167,977  3,116,421  Shares of common stock subject to outstanding common stock warrants —  3,132  Restricted stock units 4,977,616  3,077,633  Total common stock equivalents 8,145,593  6,197,186

v3.23.3

Fair Value Measurements (Tables)	9 Months Ended
	Sep. 30, 2023
Fair Value Disclosures [Abstract]
Summary of Fair Value of Financial Assets and Liabilities Measured on Recurring Basis	The following tables set forth the Company’s financial assets and liabilities, measured at fair value on a recurring basis, as of September 30, 2023 and December 31, 2022 (in thousands): September 30, 2023 Fair Value Measured Using   (Level 1) (Level 2) (Level 3) Total Balance Assets         Cash equivalents: Money market funds $ 54,405  $ —  $ —  $ 54,405  Long-term marketable securities: Corporate equity securities 992  —  —  992  Total $ 55,397  $ —  $ —  $ 55,397  Liabilities Short-term liabilities: Contingent consideration $ —  $ —  $ 2,083  $ 2,083  Long-term liabilities: Contingent consideration —  —  4,735  4,735  Total $ —  $ —  $ 6,818  $ 6,818  December 31, 2022   Fair Value Measured Using     (Level 1) (Level 2) (Level 3) Total Balance Assets         Cash equivalents: Money market funds $ 66,594  $ —  $ —  $ 66,594  Long-term marketable securities: Corporate equity securities 2,076  —  —  2,076  Total $ 68,670  $ —  $ —  $ 68,670  Liabilities Short-term liabilities: Contingent consideration $ —  $ —  $ 1,025  $ 1,025  Long-term liabilities: Contingent consideration —  —  2,418  2,418  Common stock warrant liability —  —  32  32  Total $ —  $ —  $ 3,475  $ 3,475
Summary of Issuances, Exercises, Changes in Fair Value and Reclassifications of Level 3 Financial Instruments	The following table presents the issuances, exercises, changes in fair value and reclassifications of the Company’s Level 3 financial instruments that are measured at fair value on a recurring basis (in thousands):   (Level 3) Common Stock Warrant Liability and Contingent Consideration Balance as of December 31, 2022 $ 3,475  Exercise of warrants (22) Change in estimated fair value of common stock warrant liability (10) Change in estimated fair value of contingent consideration 1,731  Addition of estimated fair value of contingent consideration 2,269  Payments related to contingent consideration (625) Balance as of September 30, 2023 $ 6,818

v3.23.3

Cash and Marketable Securities (Tables)	9 Months Ended
	Sep. 30, 2023
Cash and Cash Equivalents [Abstract]
Summary of Reconciliation of Cash and Cash Equivalents	A reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the amount reported within the condensed consolidated statements of cash flows is shown in the table below (in thousands): September 30, 2023 September 30, 2022 Cash and cash equivalents $ 75,980  $ 82,959  Restricted cash 582  198  Total cash, cash equivalents and restricted cash at the end of the period $ 76,562  $ 83,157
Summary of Marketable Securities	The amortized cost, gross unrealized holding gains (losses) and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands): September 30, 2023 Amortized Cost Unrealized Holding Gains (Losses) Fair Value Short-term marketable securities: U.S. agency securities $ 100,306  $ 1,991  $ 102,297  Corporate debt securities 91,898  584  92,482  Total short-term marketable securities 192,204  2,575  194,779  Long-term marketable securities: Corporate equity securities 5,100  (4,108) 992  Total long-term marketable securities 5,100  (4,108) 992  Total $ 197,304  $ (1,533) $ 195,771  December 31, 2022 Amortized Cost Unrealized Holding Gains (Losses) Fair Value Short-term marketable securities: U.S. agency securities $ 79,347  $ 452  $ 79,799  Corporate debt securities 123,821  (220) 123,601  Total short-term marketable securities 203,168  232  203,400  Long-term marketable securities: Corporate equity securities 5,000  (2,924) 2,076  Total long-term marketable securities 5,000  (2,924) 2,076  Total $ 208,168  $ (2,692) $ 205,476

v3.23.3

Business Combinations And Asset Acquisition (Tables)	9 Months Ended
	Sep. 30, 2023
Business Combination and Asset Acquisition [Abstract]
Summary of Identified Intangible Assets Acquired at Acquisition Date	The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands): Estimated Fair Value Estimated Useful Lives (Years) Customer relationships $ 3,010  13 Developed technology 770  11 Trademarks 320  17 Total $ 4,100  The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands): Estimated Fair Value Estimated Useful Lives (Years) Customer relationships $ 810  17 Developed technology 850  12 Trademarks 360  17 Total $ 2,020
Summary of Fair Values of Assets Acquired and Liabilities Assumed as of Acquisition Date	The following table summarizes the consideration paid for HLA Data Systems and MediGO and the provisional amounts of the assets acquired and liabilities assumed recognized at their estimated fair value at the acquisition date (in thousands): Total Consideration Cash $ 6,682  Total consideration $ 6,682  Recognized amounts of identifiable assets acquired and liabilities assumed Current assets $ 1,413  Identifiable intangible assets 6,120  Current liabilities (1,060) Other current liabilities (810) Contingent considerations (1,620) Other liabilities (7) Total identifiable net assets acquired 4,036  Goodwill 2,646  Total consideration $ 6,682

v3.23.3

Goodwill and Intangible Assets (Tables)	9 Months Ended
	Sep. 30, 2023
Goodwill and Intangible Assets Disclosure [Abstract]
Summary of Intangible Assets	The following table presents details of the Company’s intangible assets as of September 30, 2023 ($ in thousands): September 30, 2023 Gross Carrying Amount Accumulated Amortization Foreign Currency Translation Net Carrying Amount Weighted Average Remaining Useful Life (In Years) Intangible assets with finite lives: Acquired and developed technology $ 37,367  $ (17,529) $ (2,560) $ 17,278  7.4 Customer relationships 25,718  (8,663) (2,334) 14,721  9.5 Commercialization rights 11,578  (4,180) —  7,398  5.8 Trademarks and tradenames 5,220  (1,617) (356) 3,247  9.6 Total intangible assets with finite lives 79,883  (31,989) (5,250) 42,644  Intangible assets with indefinite lives: Acquired in-process technology 1,250  —  —  1,250  Favorable license agreement 2,561  —  —  2,561  Total intangible assets with indefinite lives 3,811  —  —  3,811  Total intangible assets $ 83,694  $ (31,989) $ (5,250) $ 46,455  The following table presents details of the Company’s intangible assets as of December 31, 2022 ($ in thousands): December 31, 2022 Gross Carrying Amount Accumulated Amortization Foreign Currency Translation Net Carrying Amount Weighted Average Remaining Useful Life (In Years) Intangible assets with finite lives: Acquired and developed technology $ 35,747  $ (15,138) $ (2,369) $ 18,240  7.5 Customer relationships 21,898  (7,459) (2,104) 12,335  9.0 Commercialization rights 11,579  (3,233) —  8,346  6.6 Trademarks and tradenames 4,540  (1,345) (315) 2,880  8.5 Total intangible assets with finite lives 73,764  (27,175) (4,788) 41,801  Acquired in-process technology 1,250  —  —  1,250  Total intangible assets $ 75,014  $ (27,175) $ (4,788) $ 43,051
Summary of Finite-Lived Intangible Assets Amortization Expense	The following table summarizes the Company’s amortization expense of intangible assets (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Cost of testing services $ 329  $ 329  $ 987  $ 987  Cost of product 408  415  1,242  1,305  Cost of patient and digital solutions 265  237  768  709  Sales and marketing 616  554  1,817  1,702  Total $ 1,618  $ 1,535  $ 4,814  $ 4,703
Summary of Estimated Future Amortization Expense of Intangible Assets	The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of September 30, 2023 (in thousands): Years Ending December 31, Cost of Testing Services Cost of Product Cost of Patient and Digital Solutions Sales and Marketing Total Remainder of 2023 $ 329  $ 405  $ 271  $ 634  $ 1,639  2024 1,316  1,621  850  2,494  6,281  2025 1,316  1,621  681  2,494  6,112  2026 1,316  732  681  2,492  5,221  2027 1,316  732  681  2,478  5,207  Thereafter 2,825  3,260  2,142  9,957  18,184  Total future amortization expense $ 8,418  $ 8,371  $ 5,306  $ 20,549  $ 42,644

v3.23.3

Balance Sheet Components (Tables)	9 Months Ended
	Sep. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Summary of Inventory	Inventory consisted of the following (in thousands): September 30, 2023 December 31, 2022 Finished goods $ 3,173  $ 2,962  Work in progress 4,939  4,306  Raw materials 9,866  11,964  Total inventory $ 17,978  $ 19,232
Components of Accrued and Other Liabilities	Accrued and other liabilities consisted of the following (in thousands): September 30, 2023 December 31, 2022 Clinical studies $ 14,677  $ 14,816  Professional fees 11,134  6,115  Short-term lease liability 5,958  5,591  Deferred revenue 5,766  5,342  Laboratory processing fees and materials 2,241  2,189  Contingent consideration 2,083  1,025  Accrued royalty 1,793  4,633  Deferred payments for intangible assets 920  2,062  Accrued shipping expenses 370  489  License and other collaboration fees 212  1,000  Capital expenditures —  1,316  Other accrued expenses 1,884  4,553  Total accrued and other liabilities $ 47,038  $ 49,131

v3.23.3

Commitments and Contingencies (Tables)	9 Months Ended
	Sep. 30, 2023
Commitments and Contingencies Disclosure [Abstract]
Summary of Lease Cost	The following table summarizes the lease cost for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Operating lease cost $ 1,981  $ 1,955  $ 5,936  $ 4,740  Total lease cost $ 1,981  $ 1,955  $ 5,936  $ 4,740  September 30, 2023 December 31, 2022 Other information: Weighted-average remaining lease term (in years) 5.63 6.26 Weighted-average discount rate (%) 7.1  % 7.1  % The following table summarizes the supplemental cash flow information related to leases for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows used for operating leases $ 1,172  $ 822  $ 3,871  $ 2,746
Summary ROU Assets and Lease Liabilities for Lease Agreements	The following table summarizes the ROU assets and lease liabilities for certain lease agreements which commenced in July 2022 (in thousands): September 30, 2023 December 31, 2022 ROU assets $ 12,897  $ 14,321  Lease liabilities $ 13,915  $ 15,302  The following table summarizes the ROU assets and lease liabilities for certain lease agreements which commenced in August 2022 (in thousands): September 30, 2023 December 31, 2022 ROU assets $ 5,465  $ 5,814  Lease liabilities $ 5,732  $ 6,005
Summary of Future Minimum Lease Commitments under Operating and Finance Leases	Maturities of operating lease liabilities as of September 30, 2023 are as follows (in thousands): Years Ending December 31, Operating Leases Remainder of 2023 $ 2,024  2024 7,955  2025 7,706  2026 7,019  2027 7,166  Thereafter 10,604  Total lease payments 42,474  Less imputed interest 7,264  Present value of future minimum lease payments 35,210  Less operating lease liability, current portion 5,958  Operating lease liability, long-term portion $ 29,252

v3.23.3

Stock Incentive Plans (Tables)	9 Months Ended
	Sep. 30, 2023
Share-Based Payment Arrangement [Abstract]
Summary of Options, RSUs Activity under 2014 Equity Incentive Plan and 2016 Inducement Plan and Related Information	The following table summarizes option and RSU activity under the Company’s 2014 Equity Incentive Plan, 2016 Inducement Equity Incentive Plan and 2019 Inducement Equity Incentive Plan, and related information: Shares Available for Grant Stock Options Outstanding Weighted- Average Exercise Price Number of RSU Shares Weighted- Average Grant Date Fair Value Balance—December 31, 2022 1,490,462  2,921,925  $ 28.13  3,094,396  $ 37.39  Additional shares authorized 2,141,330  —  —  —  —  Common stock awards for services (15,809) —  —  —  —  RSUs granted (3,461,674) —  —  3,461,674  11.11  RSUs vested —  —  —  (815,374) 35.90  Options granted (680,788) 680,788  12.60  —  —  Options exercised —  (23,203) 4.59  —  —  Repurchase of common stock under employee incentive plans 265,953  —  —  —  —  RSUs forfeited 761,771  —  —  (761,771) 24.67  Options forfeited 178,830  (178,830) 27.61  —  —  Options expired 236,645  (236,645) 26.93  —  —  Balance—September 30, 2023 916,720  3,164,035  $ 25.18  4,978,925  $ 21.24
Summary of Options Outstanding and Exercisable Vested or Expected to Vest	Options outstanding that have vested and are expected to vest at September 30, 2023 are as follows: Number of Shares Issued (In thousands) Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life (Years) Aggregate Intrinsic Value (In thousands) Vested 1,620  $ 26.60  6.48 $ 399  Expected to vest 1,378  23.50  8.84 —  Total 2,998  $ 399
Summary of Weighted-Average Assumptions Used to Estimate Fair Values of Share-Based Awards	The estimated fair values of employee stock options and ESPP shares were estimated using the Black-Scholes option pricing model based on the following weighted average assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Employee stock options Expected term (in years) N/A 6.0 5.6 6.0 Expected volatility N/A 78.29% 77.86% 77.58% Risk-free interest rate N/A 2.99% 3.67% 2.69% Expected dividend yield N/A —% —% —% Employee stock purchase plan Expected term (in years) 0.5 0.5 0.5 0.5 Expected volatility 93.38% 91.16% 93.38% 74.66% Risk-free interest rate 5.53% 3.92% 5.49% 2.92% Expected dividend yield —% —% —% —%
Summary of Expense Relating to Employee and Nonemployee Stock-Based Payment Awards from Stock Options and RSUs	The following table summarizes stock-based compensation expense relating to employee and non-employee stock-based awards for the three and nine months ended September 30, 2023 and 2022, included in the condensed consolidated statements of operations as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Cost of testing services $ 496  $ 470  $ 1,467  $ 1,055  Cost of product 301  321  935  851  Cost of patient and digital solutions 297  299  1,066  882  Research and development 1,491  2,058  5,157  6,571  Sales and marketing 3,041  2,672  9,557  9,702  General and administrative 7,045  5,380  20,943  15,366  Total $ 12,671  $ 11,200  $ 39,125  $ 34,427

v3.23.3

Segment Reporting (Tables)	9 Months Ended
	Sep. 30, 2023
Segment Reporting [Abstract]
Summary of Reportable Revenues by Geographic Regions	The following table summarizes reportable revenues by geographic regions (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Testing services revenue United States $ 47,644  $ 64,547  $ 162,560  $ 197,675  Rest of World 140  204  422  655  $ 47,784  $ 64,751  $ 162,982  $ 198,330  Product revenue United States $ 5,810  $ 4,245  $ 13,857  $ 11,435  Europe 2,437  2,262  7,430  6,887  Rest of World 1,289  687  2,986  2,374  $ 9,536  $ 7,194  $ 24,273  $ 20,696  Patient and digital solutions revenue United States $ 9,735  $ 7,187  $ 27,130  $ 19,865  Europe 34  209  239  429  Rest of World 103  18  131  89  $ 9,872  $ 7,414  $ 27,500  $ 20,383  Total United States $ 63,189  $ 75,979  $ 203,547  $ 228,975  Total Europe $ 2,471  $ 2,471  $ 7,669  $ 7,316  Total Rest of World $ 1,532  $ 909  $ 3,539  $ 3,118  Total $ 67,192  $ 79,359  $ 214,755  $ 239,409
Summary of Long-Lived Assets Consisting of Property and Equipment, Net by Geographic Regions	The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions (in thousands): September 30, 2023 December 31, 2022 Long-lived assets: United States $ 34,815  $ 35,020  Europe 471  405  Rest of World 69  104  Total $ 35,355  $ 35,529

v3.23.3

Organization and Description of Business (Details)				3 Months Ended			9 Months Ended		23 Months Ended
	May 09, 2023 USD ($)	Apr. 01, 2023 USD ($)	Dec. 08, 2022	Sep. 30, 2023 USD ($) shares	Jun. 30, 2023 USD ($)	Sep. 30, 2022 USD ($)	Sep. 30, 2023 USD ($) unique_solution shares	Sep. 30, 2022 USD ($)	Mar. 31, 2023 USD ($) test claim	Dec. 31, 2022 USD ($)	Dec. 03, 2022 USD ($)	Jan. 31, 2018 patient
Schedule of Capitalization, Equity [Line Items]
Reimbursement claims | test									3,200
Received repayment recognized revenue				$ 67,192,000		$ 79,359,000	$ 214,755,000	$ 239,409,000
Number of renal transplant patients (more than) | patient												1,700
Accumulated deficit				534,202,000			534,202,000			$ 460,444,000
Cash, cash equivalents, and short-term investments				$ 268,200,000			$ 268,200,000
Stock repurchase program, authorized amount											$ 50,000,000
Stock repurchase program, period in force			2 years
Number of common stock purchased (in shares) | shares				92,766			164,238
Stock repurchased value				$ 800,000			$ 1,600,000
Stock repurchase program, remaining authorized repurchase amount				$ 47,700,000			$ 47,700,000
Miromatrix, Inc.
Schedule of Capitalization, Equity [Line Items]
Payments to acquire minority interest									$ 5,100,000
XynManagement, Inc.
Schedule of Capitalization, Equity [Line Items]
Number of unique solutions | unique_solution							2
AlloSure Kidney
Schedule of Capitalization, Equity [Line Items]
Reimbursement rate							$ 2,841
AlloMap Heart
Schedule of Capitalization, Equity [Line Items]
Reimbursement rate							3,240
AlloSure Heart
Schedule of Capitalization, Equity [Line Items]
Reimbursement rate							$ 2,753
AlloSure lung Testing Services
Schedule of Capitalization, Equity [Line Items]
Reimbursement rate	$ 2,753
Revenue not yet recognized									$ 8,900,000
HeartCare
Schedule of Capitalization, Equity [Line Items]
Reimbursement rate		$ 5,993
Medicare | AlloSure Kidney
Schedule of Capitalization, Equity [Line Items]
Reimbursement claims | claim									3,200
Noridian | AlloSure Kidney
Schedule of Capitalization, Equity [Line Items]
Received repayment recognized revenue					$ 7,800,000

v3.23.3

Summary of Significant Accounting Policies - Concentration of Credit Risk (Details) - Medicare	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Revenue Benchmark | Customer Concentration Risk
Concentration Risk [Line Items]
Concentration risk percentage	36.00%	53.00%	41.00%	54.00%
Accounts Receivable | Credit Concentration Risk
Concentration Risk [Line Items]
Concentration risk percentage			36.00%		27.00%

v3.23.3

Summary of Significant Accounting Policies - Leases (Details)	9 Months Ended
	Sep. 30, 2023
Minimum
Summary Of Significant Accounting Policies [Line Items]
Remaining lease terms	2 months 1 day
Maximum
Summary Of Significant Accounting Policies [Line Items]
Remaining lease terms	9 years 4 months 6 days

v3.23.3

Summary of Significant Accounting Policies - Revenue (Details) $ in Thousands	3 Months Ended			9 Months Ended
	Sep. 30, 2023 USD ($)	Jun. 30, 2023 USD ($)	Sep. 30, 2022 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2022 USD ($)	Mar. 31, 2023 USD ($) test
Revenue from External Customer [Line Items]
Reimbursement claims | test						3,200
Total revenue	$ 67,192		$ 79,359	$ 214,755	$ 239,409
AlloSure lung Testing Services
Revenue from External Customer [Line Items]
Revenue not yet recognized						$ 8,900
Noridian | AlloSure Kidney
Revenue from External Customer [Line Items]
Total revenue		$ 7,800

v3.23.3

Net Loss Per Share - Summary of Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Numerator:
Net loss used to compute basic net loss per share	$ (23,485)	$ (16,939)	$ (72,187)	$ (58,284)
Net loss used to compute diluted net loss per share	$ (23,485)	$ (16,939)	$ (72,187)	$ (58,284)
Denominator:
Weighted-average shares used to compute basic net loss per share (in shares)	54,178,759	53,489,418	53,891,374	53,253,210
Weighted-average shares used to compute diluted net loss per share (in shares)	54,178,759	53,489,418	53,891,374	53,253,210
Net loss per share:
Basic (in dollars per share)	$ (0.43)	$ (0.32)	$ (1.34)	$ (1.09)
Diluted (in dollars per share)	$ (0.43)	$ (0.32)	$ (1.34)	$ (1.09)

v3.23.3

Net Loss Per Share - Summary of Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders (in shares)	8,145,593	6,197,186	8,145,593	6,197,186
Shares of common stock subject to outstanding options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders (in shares)	3,167,977	3,116,421	3,167,977	3,116,421
Shares of common stock subject to outstanding common stock warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders (in shares)	0	3,132	0	3,132
Restricted stock units
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders (in shares)	4,977,616	3,077,633	4,977,616	3,077,633

v3.23.3

Fair Value Measurements - Summary of Fair Value of Financial Assets and Liabilities Measured on Recurring Basis (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Short-term liabilities:
Contingent consideration	$ 2,083	$ 1,025
Recurring
Assets
Total	55,397	68,670
Short-term liabilities:
Contingent consideration	2,083	1,025
Long-term liabilities:
Contingent consideration	4,735	2,418
Common stock warrant liability		32
Total	6,818	3,475
Recurring | Money market funds
Assets
Cash equivalents	54,405	66,594
Recurring | Corporate equity securities
Assets
Corporate equity securities	992	2,076
Fair Value Measured Using - (Level 1) | Recurring
Assets
Total	55,397	68,670
Short-term liabilities:
Contingent consideration	0	0
Long-term liabilities:
Contingent consideration	0	0
Common stock warrant liability		0
Total	0	0
Fair Value Measured Using - (Level 1) | Recurring | Money market funds
Assets
Cash equivalents	54,405	66,594
Fair Value Measured Using - (Level 1) | Recurring | Corporate equity securities
Assets
Corporate equity securities	992	2,076
Fair Value Measured Using - (Level 2) | Recurring
Assets
Total	0	0
Short-term liabilities:
Contingent consideration	0	0
Long-term liabilities:
Contingent consideration	0	0
Common stock warrant liability		0
Total	0	0
Fair Value Measured Using - (Level 2) | Recurring | Money market funds
Assets
Cash equivalents	0	0
Fair Value Measured Using - (Level 2) | Recurring | Corporate equity securities
Assets
Corporate equity securities	0	0
Fair Value Measured Using - (Level 3) | Recurring
Assets
Total	0	0
Short-term liabilities:
Contingent consideration	2,083	1,025
Long-term liabilities:
Contingent consideration	4,735	2,418
Common stock warrant liability		32
Total	6,818	3,475
Fair Value Measured Using - (Level 3) | Recurring | Money market funds
Assets
Cash equivalents	0	0
Fair Value Measured Using - (Level 3) | Recurring | Corporate equity securities
Assets
Corporate equity securities	$ 0	$ 0

v3.23.3

Fair Value Measurements - Summary of Issuances, Exercises, Changes in Fair Value and Reclassifications of Level 3 Financial Instruments (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2023 USD ($)
Common Stock Warrant Liability and Contingent Consideration
Beginning balance	$ 3,475
Exercise of warrants	(22)
Ending balance	6,818
Common Stock Warrant Liability
Common Stock Warrant Liability and Contingent Consideration
Change in estimated fair value of common stock warrant liability and contingent consideration	(10)
Contingent Consideration
Common Stock Warrant Liability and Contingent Consideration
Change in estimated fair value of common stock warrant liability and contingent consideration	1,731
Addition of estimated fair value of contingent consideration	2,269
Payments related to contingent consideration	$ (625)

v3.23.3

Fair Value Measurements - Additional Information (Details) $ in Millions	1 Months Ended	9 Months Ended	12 Months Ended
	Mar. 31, 2023 USD ($)	Sep. 30, 2023	Dec. 31, 2022
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Write-off of investments in convertible preferred shares	$ 1.0
Contingent consideration, measurement input, discount rate			0.12
Minimum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Contingent consideration, measurement input, discount rate		0.07
Maximum
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Contingent consideration, measurement input, discount rate		0.12

v3.23.3

Cash and Marketable Securities - Summary of Reconciliation of Cash and Cash Equivalents (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022	Sep. 30, 2022	Dec. 31, 2021
Cash and Cash Equivalents [Abstract]
Cash and cash equivalents	$ 75,980	$ 89,921	$ 82,959
Restricted cash	582	522	198
Total cash, cash equivalents and restricted cash at the end of the period	$ 76,562	$ 90,443	$ 83,157	$ 348,696

v3.23.3

Cash and Marketable Securities - Summary of Components of Marketable Securities (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Short-term marketable securities:
Amortized Cost	$ 192,204	$ 203,168
Unrealized Holding Gains (Losses)	2,575	232
Fair Value	194,779	203,400
Long-term marketable securities:
Amortized Cost	5,100	5,000
Unrealized Holding Gains (Losses)	(4,108)	(2,924)
Fair Value	992	2,076
Amortized Cost	197,304	208,168
Unrealized Holding Gains (Losses)	(1,533)	(2,692)
Fair Value	195,771	205,476
U.S. agency securities
Short-term marketable securities:
Debt securities, amortized cost	100,306	79,347
Unrealized holding gain	1,991	452
Debt securities, fair value	102,297	79,799
Corporate debt securities
Short-term marketable securities:
Debt securities, amortized cost	91,898	123,821
Unrealized holding gain	584
Unrealized holding loss		(220)
Debt securities, fair value	92,482	123,601
Corporate equity securities
Long-term marketable securities:
Corporate equity securities, amortized cost	5,100	5,000
Corporate equity securities, unrealized holding gains (losses)	(4,108)	(2,924)
Corporate equity securities	$ 992	$ 2,076

v3.23.3

Business Combinations And Asset Acquisition - Additional Information (Details)		1 Months Ended
	Aug. 09, 2023 USD ($)	Jul. 31, 2023 USD ($)	Jan. 31, 2023 USD ($)	Sep. 30, 2023 USD ($)	Dec. 31, 2022 USD ($)
Business Acquisition [Line Items]
Goodwill				$ 40,208,000	$ 37,523,000
Asset acquisition, consideration transferred	$ 2,600,000
Payments to acquire productive assets	1,800,000
Contingent consideration	500,000
Transaction cost	$ 300,000
HLA Data Systems
Business Acquisition [Line Items]
Fair value of contingent consideration			$ 1,300,000
Acquisition related costs			400,000
Goodwill			2,100,000
Goodwill expected to be deductible for income tax purposes			$ 0
HLA Data Systems | Discount Rate
Business Acquisition [Line Items]
Intangible asset, measurement input (percent)			0.24
HLA Data Systems | Developed technology | Royalty Rate
Business Acquisition [Line Items]
Intangible asset, measurement input (percent)			0.10
HLA Data Systems | Trademarks | Royalty Rate
Business Acquisition [Line Items]
Intangible asset, measurement input (percent)			0.02
MediGO
Business Acquisition [Line Items]
Fair value of contingent consideration		$ 300,000
Acquisition related costs		300,000
Goodwill		600,000
Goodwill expected to be deductible for income tax purposes		$ 0
MediGO | Discount Rate
Business Acquisition [Line Items]
Intangible asset, measurement input (percent)		0.25
MediGO | Developed technology | Royalty Rate
Business Acquisition [Line Items]
Intangible asset, measurement input (percent)		0.10
MediGO | Trademarks | Royalty Rate
Business Acquisition [Line Items]
Intangible asset, measurement input (percent)		0.02

v3.23.3

Business Combinations And Asset Acquisition - Summary of Identified Intangible Assets Acquired at Acquisition Date (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Jul. 31, 2023	Jan. 31, 2023	Dec. 31, 2022
HLA Data Systems
Business Acquisition [Line Items]
Estimated Fair Value			$ 4,100
MediGO
Business Acquisition [Line Items]
Estimated Fair Value		$ 2,020
Customer relationships
Business Acquisition [Line Items]
Estimated Useful Lives (Years)	9 years 6 months			9 years
Customer relationships | HLA Data Systems
Business Acquisition [Line Items]
Estimated Fair Value			$ 3,010
Estimated Useful Lives (Years)			13 years
Customer relationships | MediGO
Business Acquisition [Line Items]
Estimated Fair Value		$ 810
Estimated Useful Lives (Years)		17 years
Developed technology | HLA Data Systems
Business Acquisition [Line Items]
Estimated Fair Value			$ 770
Estimated Useful Lives (Years)			11 years
Developed technology | MediGO
Business Acquisition [Line Items]
Estimated Fair Value		$ 850
Estimated Useful Lives (Years)		12 years
Trademarks | HLA Data Systems
Business Acquisition [Line Items]
Estimated Fair Value			$ 320
Estimated Useful Lives (Years)			17 years
Trademarks | MediGO
Business Acquisition [Line Items]
Estimated Fair Value		$ 360
Estimated Useful Lives (Years)		17 years

v3.23.3

Business Combinations And Asset Acquisition - Summary of Consideration Paid and Provisional Amounts of Assets Acquired and Liabilities Assumed Recognized at Their Estimated Fair Value (Details) - USD ($) $ in Thousands	1 Months Ended
	Jul. 31, 2023	Sep. 30, 2023	Dec. 31, 2022
Business Acquisition [Line Items]
Goodwill		$ 40,208	$ 37,523
HLA Data Systems And MediGO
Business Acquisition [Line Items]
Cash	$ 6,682
Total consideration	6,682
Current assets	1,413
Identifiable intangible assets	6,120
Current liabilities	(1,060)
Other current liabilities	(810)
Contingent considerations	(1,620)
Other liabilities	(7)
Total identifiable net assets acquired	4,036
Goodwill	2,646
Total consideration	$ 6,682

v3.23.3

Goodwill and Intangible Assets - Additional Information (Details) - USD ($)	9 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Goodwill And Intangible Assets [Line Items]
Goodwill	$ 40,208,000	$ 37,523,000
Goodwill, impairment loss	$ 0
Discount Rate
Goodwill And Intangible Assets [Line Items]
Discount rate (in percentage)	16.40%

v3.23.3

Goodwill and Intangible Assets - Summary of Intangible Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Intangible assets with finite lives:
Gross Carrying Amount	$ 79,883	$ 73,764
Accumulated Amortization	(31,989)	(27,175)
Foreign Currency Translation	(5,250)	(4,788)
Total future amortization expense	42,644	41,801
Intangible assets with indefinite lives
Net carrying amount	3,811
Intangible Assets, Net (Excluding Goodwill)
Total intangible assets - gross carrying amount	83,694	75,014
Total intangible assets, net	46,455	43,051
Acquired in-process technology
Intangible assets with indefinite lives
Net carrying amount	1,250	1,250
Favorable license agreement
Intangible assets with indefinite lives
Net carrying amount	2,561
Acquired and developed technology
Intangible assets with finite lives:
Gross Carrying Amount	37,367	35,747
Accumulated Amortization	(17,529)	(15,138)
Foreign Currency Translation	(2,560)	(2,369)
Total future amortization expense	$ 17,278	$ 18,240
Weighted Average Remaining Useful Life (In Years)	7 years 4 months 24 days	7 years 6 months
Customer relationships
Intangible assets with finite lives:
Gross Carrying Amount	$ 25,718	$ 21,898
Accumulated Amortization	(8,663)	(7,459)
Foreign Currency Translation	(2,334)	(2,104)
Total future amortization expense	$ 14,721	$ 12,335
Weighted Average Remaining Useful Life (In Years)	9 years 6 months	9 years
Commercialization rights
Intangible assets with finite lives:
Gross Carrying Amount	$ 11,578	$ 11,579
Accumulated Amortization	(4,180)	(3,233)
Foreign Currency Translation	0	0
Total future amortization expense	$ 7,398	$ 8,346
Weighted Average Remaining Useful Life (In Years)	5 years 9 months 18 days	6 years 7 months 6 days
Trademarks and tradenames
Intangible assets with finite lives:
Gross Carrying Amount	$ 5,220	$ 4,540
Accumulated Amortization	(1,617)	(1,345)
Foreign Currency Translation	(356)	(315)
Total future amortization expense	$ 3,247	$ 2,880
Weighted Average Remaining Useful Life (In Years)	9 years 7 months 6 days	8 years 6 months

v3.23.3

Goodwill and Intangible Assets - Summary of Finite-Lived Intangible Assets Amortization Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Indefinite-lived Intangible Assets [Line Items]
Amortization expense of intangible assets	$ 1,618	$ 1,535	$ 4,814	$ 4,703
Cost of Testing Services
Indefinite-lived Intangible Assets [Line Items]
Amortization expense of intangible assets	329	329	987	987
Cost of Product
Indefinite-lived Intangible Assets [Line Items]
Amortization expense of intangible assets	408	415	1,242	1,305
Cost of Patient and Digital Solutions
Indefinite-lived Intangible Assets [Line Items]
Amortization expense of intangible assets	265	237	768	709
Sales and marketing
Indefinite-lived Intangible Assets [Line Items]
Amortization expense of intangible assets	$ 616	$ 554	$ 1,817	$ 1,702

v3.23.3

Goodwill and Intangible Assets - Summary of Estimated Future Amortization Expense of Intangible Assets with Finite Lives (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]
Remainder of 2023	$ 1,639
2024	6,281
2025	6,112
2026	5,221
2027	5,207
Thereafter	18,184
Total future amortization expense	42,644	$ 41,801
Cost of Testing Services
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]
Remainder of 2023	329
2024	1,316
2025	1,316
2026	1,316
2027	1,316
Thereafter	2,825
Total future amortization expense	8,418
Cost of Product
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]
Remainder of 2023	405
2024	1,621
2025	1,621
2026	732
2027	732
Thereafter	3,260
Total future amortization expense	8,371
Cost of Patient and Digital Solutions
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]
Remainder of 2023	271
2024	850
2025	681
2026	681
2027	681
Thereafter	2,142
Total future amortization expense	5,306
Sales and Marketing
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]
Remainder of 2023	634
2024	2,494
2025	2,494
2026	2,492
2027	2,478
Thereafter	9,957
Total future amortization expense	$ 20,549

v3.23.3

Balance Sheet Components - Summary of Inventory (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Finished goods	$ 3,173	$ 2,962
Work in progress	4,939	4,306
Raw materials	9,866	11,964
Total inventory	$ 17,978	$ 19,232

v3.23.3

Balance Sheet Components - Components of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Clinical studies	$ 14,677	$ 14,816
Professional fees	11,134	6,115
Short-term lease liability	5,958	5,591
Deferred revenue	5,766	5,342
Laboratory processing fees and materials	2,241	2,189
Contingent consideration	2,083	1,025
Accrued royalty	1,793	4,633
Deferred payments for intangible assets	920	2,062
Accrued shipping expenses	370	489
License and other collaboration fees	212	1,000
Capital expenditures	0	1,316
Other accrued expenses	1,884	4,553
Accrued and other liabilities	$ 47,038	$ 49,131

v3.23.3

Commitments and Contingencies - Additional Information (Details)			1 Months Ended
	May 13, 2022 complaint	Mar. 14, 2022 USD ($)	May 31, 2023	Dec. 31, 2022 USD ($)	Jun. 30, 2022 USD ($)	Jun. 30, 2014 milestone_payment	Sep. 30, 2023 USD ($)	Jun. 30, 2023 USD ($)	Feb. 28, 2022
Loss Contingencies [Line Items]
Operating leases right-of-use assets				$ 34,689,000			$ 30,973,000
Short-term lease liability				5,591,000			5,958,000
Operating lease liability, less current portion				33,406,000			$ 29,252,000
Operating lease, liability, current, statement of financial position [Extensible Enumeration]							Accrued and other liabilities
Decrease in ROU asset					$ 500,000
Operating lease, impairment loss					$ 500,000
Number of milestone payments | milestone_payment						6
Period after termination			90 days
Insurance matter				$ 15,000,000
Cibiltech Commitments
Loss Contingencies [Line Items]
Outstanding obligation							$ 0	$ 400,000
Minimum
Loss Contingencies [Line Items]
Lessee, operating lease, term of contract					2 years				2 years
Operating lease, extension period					5 years				5 years
Maximum
Loss Contingencies [Line Items]
Lessee, operating lease, term of contract					10 years 6 months				10 years 6 months
Operating lease, extension period					10 years				10 years
CAREDX, INC. vs Natera Inc.
Loss Contingencies [Line Items]
Damages awarded		$ 44,900,000
Number of claims field | complaint	2
CAREDX, INC. vs Natera Inc. | Compensatory Damages
Loss Contingencies [Line Items]
Damages awarded		21,200,000
CAREDX, INC. vs Natera Inc. | Punitive Damages
Loss Contingencies [Line Items]
Damages awarded		$ 23,700,000

v3.23.3

Commitments and Contingencies - Summary of Lease Cost (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Commitments and Contingencies Disclosure [Abstract]
Operating lease cost	$ 1,981	$ 1,955	$ 5,936	$ 4,740
Total lease cost	$ 1,981	$ 1,955	$ 5,936	$ 4,740

v3.23.3

Commitments and Contingencies - Summary of Other Information Related to Lease (Details)	Sep. 30, 2023	Dec. 31, 2022
Other information:
Weighted-average remaining lease term (in years)	5 years 7 months 17 days	6 years 3 months 3 days
Weighted-average discount rate (%)	7.10%	7.10%

v3.23.3

Commitments and Contingencies - Summarizes ROU Assets and Lease Liabilities for Lease Agreements (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Loss Contingencies [Line Items]
ROU assets	$ 30,973	$ 34,689
Lease liabilities	35,210
Leases, Commenced In July 2022
Loss Contingencies [Line Items]
ROU assets	12,897	14,321
Lease liabilities	13,915	15,302
Leases, Commenced In August 2022
Loss Contingencies [Line Items]
ROU assets	5,465	5,814
Lease liabilities	$ 5,732	$ 6,005

v3.23.3

Commitments and Contingencies - Schedule of Future Minimum Lease Commitments under Operating and Finance Leases (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Operating Leases
Remainder of 2023	$ 2,024
2024	7,955
2025	7,706
2026	7,019
2027	7,166
Thereafter	10,604
Total lease payments	42,474
Less imputed interest	7,264
Present value of future minimum lease payments	35,210
Less operating lease liability, current portion	5,958	$ 5,591
Operating lease liability, long-term portion	$ 29,252	$ 33,406

v3.23.3

Commitments and Contingencies - Summarizes the Noncash Information (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Commitments and Contingencies Disclosure [Abstract]
Operating cash flows used for operating leases	$ 1,172	$ 822	$ 3,871	$ 2,746

v3.23.3

401(K) Plan (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Retirement Benefits [Abstract]
Defined benefit plan, type			Postemployment Retirement Benefits [Member]
Expense incurred related to plan	$ 0.2	$ 0.3	$ 1.4	$ 1.5

v3.23.3

Warrants (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Warrants and Rights Note Disclosure [Abstract]
Number of warrants exercised (in shares)	0	0		0
Number of shares of common stock warranted (in shares)	3,000		3,000
Proceeds from exercise of warrants			$ 4	$ 0

v3.23.3

Stock Incentive Plans - Summary of Option, Unvested RSU Activity under 2014 Equity Incentive Plan and 2016 Inducement Equity Incentive Plan and Related Information (Details)	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Shares Available for Grant
Shares available for grant beginning balance (in shares)	1,490,462
Additional options authorized (in shares)	2,141,330
Common stock awards for services (in shares)	(15,809)
RSUs granted (in shares)	(3,461,674)
Options granted (in shares)	(680,788)
Repurchase of common stock under employee incentive plans (in shares)	265,953
RSUs forfeited (in shares)	761,771
Options forfeited (in shares)	178,830
Options expired (in shares)	236,645
Shares available for grant ending balance (in shares)	916,720
Stock Options Outstanding
Stock options outstanding beginning balance (in shares)	2,921,925
Stock options granted (in shares)	680,788
Stock options exercised (in shares)	(23,203)
Stock options forfeited (in shares)	(178,830)
Stock options expired (in shares)	(236,645)
Stock options outstanding ending balance (in shares)	3,164,035
Weighted- Average Exercise Price
Weighted average exercise price beginning balance (in dollars per share) | $ / shares	$ 28.13
Weighted average exercise price - options granted (in dollars per share) | $ / shares	12.60
Weighted average exercise price - options exercised (in dollars per share) | $ / shares	4.59
Weighted average exercise price - options forfeited (in dollars per share) | $ / shares	27.61
Weighted average exercise price - options expired (in dollars per share) | $ / shares	26.93
Weighted average exercise price ending balance (in dollars per share) | $ / shares	$ 25.18
Number of RSU Shares
RSUs granted (in shares)	3,461,674
RSUs forfeited (in shares)	(761,771)
Restricted Stock Units
Shares Available for Grant
RSUs granted (in shares)	(3,461,674)
RSUs forfeited (in shares)	761,771
Number of RSU Shares
Number of RSU shares beginning balance (in shares)	3,094,396
RSUs granted (in shares)	3,461,674
RSUs vested (in shares)	(815,374)
RSUs forfeited (in shares)	(761,771)
Number of RSU shares ending balance (in shares)	4,978,925
Weighted- Average Grant Date Fair Value
Weighted average grant date fair value beginning balance (in dollars per share) | $ / shares	$ 37.39
Weighted average grant date fair value - RSUs granted (in dollars per share) | $ / shares	11.11
Weighted average grant date fair value - RSUs vested (in dollars per share) | $ / shares	35.90
Weighted average grant date fair value - RSUs forfeited (in dollars per share) | $ / shares	24.67
Weighted average grant date fair value ending balance (in dollars per share) | $ / shares	$ 21.24

v3.23.3

Stock Incentive Plans - Additional Information (Details) - USD ($)			3 Months Ended		9 Months Ended
	Jul. 06, 2023	Jan. 02, 2023	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total intrinsic value of options exercised			$ 74,000	$ 100,000	$ 100,000	$ 1,300,000
Total fair value of options vested during period					15,600,000
Share-based compensation expense tax benefit recognized					0
Share-based compensation expense capitalized					$ 0
2014 Employee Stock Purchase Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Maximum portion of earning an employee may contribute to the ESPP Plan			15.00%		15.00%
Maximum value of shares which an employee can purchase per calendar year					$ 25,000
Offering period for employee stock purchases					6 months
Applicable exercise date an offering period shall be equal to percentage of the lower of fair market value of common stock					85.00%
Shares issued under ESPP (in shares)	143,817	47,025
Aggregate proceeds from the issuance of shares	$ 1,000,000	$ 500,000
Restricted Stock Units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Intrinsic value of RSUs			$ 35,800,000		$ 35,800,000
Total unrecognized compensation costs related to stock options and RSUs			63,600,000		$ 63,600,000
Stock options and RSUs expected weighted average period					2 years 6 months 3 days
Employee Stock Option
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total unrecognized compensation costs related to stock options and RSUs			20,400,000		$ 20,400,000
Stock options and RSUs expected weighted average period					2 years 4 months 24 days
Total fair value of options vested during period			$ 3,200,000

v3.23.3

Stock Incentive Plans - Summary of Options Outstanding Vested and Expected to Vest (Details) $ / shares in Units, $ in Thousands	9 Months Ended
	Sep. 30, 2023 USD ($) $ / shares shares
Share-Based Payment Arrangement [Abstract]
Vested (in shares) | shares	1,620
Expected to vest (in shares) | shares	1,378
Total (in shares) | shares	2,998
Vested (in dollars per share) | $ / shares	$ 26.60
Expected to vest (in dollars per share) | $ / shares	$ 23.50
Vested, weighted-average remaining contractual life (years)	6 years 5 months 23 days
Expected to vest, weighted-average remaining contractual life (years)	8 years 10 months 2 days
Vested, aggregate intrinsic value | $	$ 399
Expected to vest, aggregate intrinsic value | $	0
Total, aggregate intrinsic value | $	$ 399

v3.23.3

Stock Incentive Plans - Summary of Weighted-Average Assumptions Used to Estimated Fair Values of Share-Based Awards (Details)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Employee stock purchase plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (in years)	6 months	6 months	6 months	6 months
Expected volatility	93.38%	91.16%	93.38%	74.66%
Risk-free interest rate	5.53%	3.92%	5.49%	2.92%
Expected dividend yield	0.00%	0.00%	0.00%	0.00%
Employee stock options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (in years)		6 years	5 years 7 months 6 days	6 years
Expected volatility		78.29%	77.86%	77.58%
Risk-free interest rate		2.99%	3.67%	2.69%
Expected dividend yield		0.00%	0.00%	0.00%

v3.23.3

Stock Incentive Plans - Summary of Expense Relating to Employee and Nonemployee Stock-Based Payment Awards from Stock Options and RSUs (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share based compensation expense	$ 12,671	$ 11,200	$ 39,125	$ 34,427
Cost of testing services
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share based compensation expense	496	470	1,467	1,055
Cost of product
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share based compensation expense	301	321	935	851
Cost of patient and digital solutions
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share based compensation expense	297	299	1,066	882
Research and development
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share based compensation expense	1,491	2,058	5,157	6,571
Sales and marketing
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share based compensation expense	3,041	2,672	9,557	9,702
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share based compensation expense	$ 7,045	$ 5,380	$ 20,943	$ 15,366

v3.23.3

Income Taxes (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Income Tax Disclosure [Abstract]
Income tax benefit (expense)	$ 80,000	$ (267,000)	$ 24,000	$ (206,000)

v3.23.3

Segment Reporting - Summary of Reportable Revenues by Geographic Regions (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Segment Reporting Information [Line Items]
Total revenue	$ 67,192	$ 79,359	$ 214,755	$ 239,409
United States
Segment Reporting Information [Line Items]
Total revenue	63,189	75,979	203,547	228,975
Europe
Segment Reporting Information [Line Items]
Total revenue	2,471	2,471	7,669	7,316
Rest of World
Segment Reporting Information [Line Items]
Total revenue	1,532	909	3,539	3,118
Testing services revenue
Segment Reporting Information [Line Items]
Total revenue	47,784	64,751	162,982	198,330
Testing services revenue | United States
Segment Reporting Information [Line Items]
Total revenue	47,644	64,547	162,560	197,675
Testing services revenue | Rest of World
Segment Reporting Information [Line Items]
Total revenue	140	204	422	655
Product revenue
Segment Reporting Information [Line Items]
Total revenue	9,536	7,194	24,273	20,696
Product revenue | United States
Segment Reporting Information [Line Items]
Total revenue	5,810	4,245	13,857	11,435
Product revenue | Europe
Segment Reporting Information [Line Items]
Total revenue	2,437	2,262	7,430	6,887
Product revenue | Rest of World
Segment Reporting Information [Line Items]
Total revenue	1,289	687	2,986	2,374
Patient and digital solutions revenue
Segment Reporting Information [Line Items]
Total revenue	9,872	7,414	27,500	20,383
Patient and digital solutions revenue | United States
Segment Reporting Information [Line Items]
Total revenue	9,735	7,187	27,130	19,865
Patient and digital solutions revenue | Europe
Segment Reporting Information [Line Items]
Total revenue	34	209	239	429
Patient and digital solutions revenue | Rest of World
Segment Reporting Information [Line Items]
Total revenue	$ 103	$ 18	$ 131	$ 89

v3.23.3

Segment Reporting - Summary of Long-Lived Assets Consisting of Property and Equipment, Net by Geographic Regions (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Segment Reporting Information [Line Items]
Long-lived assets	$ 35,355	$ 35,529
United States
Segment Reporting Information [Line Items]
Long-lived assets	34,815	35,020
Europe
Segment Reporting Information [Line Items]
Long-lived assets	471	405
Rest of World
Segment Reporting Information [Line Items]
Long-lived assets	$ 69	$ 104

v3.23.3

Restructuring (Details) - USD ($)	3 Months Ended			9 Months Ended
	Sep. 30, 2023	Jun. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Restructuring Cost and Reserve [Line Items]
Restructuring costs	$ 0		$ 0	$ 848,000	$ 0
Employee Severance
Restructuring Cost and Reserve [Line Items]
Restructuring costs	$ 0	$ 800,000

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