Oncocyte Announces Market Entry and Early Adopter Program for Transplant Rejection Monitoring Business
July 13 2022 - 8:00AM
Oncocyte Corporation (Nasdaq: OCX) today announced that it has
completed development and clinical validation of the Laboratory
Test for its newly-branded VitaGraft™ Transplant Monitoring tests
for Liver and Kidney, entering a $2B US market. The company also
opened an Early Adopter Program (EAP) giving access to leading
transplant centers prior to a potential CMS coverage decision and
full commercial launch. VitaGraft, formerly branded as Therasure™,
is a patented, proprietary test built upon the IP acquired in the
Chronix Biomedical acquisition last year.
“In less than nine months, we have completed
tech transfer, developed and completed clinical validation of the
VitaGraft program in both Liver and Kidney, and submitted for
Medicare reimbursement,” said Ron Andrews, CEO of Oncocyte. “I’m
also pleased to announce that, on a parallel path, we have
initiated development of the VitaGraft IVD assay. Our goal is to
utilize our patented technology to support better care and faster
access to results for patients and physicians in the transplant
community. We look forward to giving regular updates on our
progress as we anticipate achieving reimbursement and launching our
FDA study over the next several quarters.”
VitaGraft has been well-studied across Kidney,
Liver, and Heart with over 20 peer-reviewed publications from
studies in over 600 patients and over 5,000 samples. The test can
serve an important need in managing transplant patients. It is a
simple and non-invasive blood test that has been shown to
accurately rule-out rejection or injury following transplant with
negative predictive values above 97%, helping avoid around 30% of
unnecessary biopsies. Furthermore, the test can assist physicians
in optimizing dosing of immunosuppressive drugs, to minimize drug
related side effects and toxicity.
“We have built a simple workflow that can be
automated and potentially provide best in class turnaround time of
results,” commented Dr Ekke Schütz, CTO of Oncocyte and former CEO
and CMO of Chronix. “I am extremely proud of the R&D and CLIA
teams on both sides of the Atlantic for the incredible teamwork to
rapidly deliver a test that can have a profound impact on
transplant patient management.”
About OncocyteOncocyte is a precision
diagnostics company with a mission to improve patient outcomes by
providing personalized insights that inform critical decisions
throughout the patient care journey.
Through its proprietary tests and pharmaceutical
services business, the Company aims to help save lives by
accelerating the diagnosis of cancer and advancing cancer care. The
Company’s tests are designed to help provide clarity and confidence
to physicians and their patients at every stage. DetermaRx™
identifies early-stage lung cancer patients who are at high risk
for cancer recurrence and who may benefit from adjuvant
chemotherapy. DetermaIO™ is a gene expression test that assesses
the tumor microenvironment to predict response to immunotherapies.
The Company’s pipeline of tests in development also includes
DetermaTx™, which will assess mutational status of a tumor,
DetermaCNI™, a blood-based monitoring test, DetermaMx™, a long-term
recurrence monitoring test, and VitaGraft™, a blood-based solid
organ transplantation monitoring test. In addition, Oncocyte’s
pharmaceutical services provide companies that are developing new
cancer treatments a full suite of molecular testing services to
support the drug development process.
DetermaRx™, DetermaIO™, DetermaTx™, DetermaCNI™,
DetermaMx™ and VitaGraft™ are trademarks of Oncocyte
Corporation.
Forward-Looking Statements
Any statements that are not historical fact
(including, but not limited to statements that contain words such
as “will,” “believes,” “plans,” “anticipates,” “expects,”
“estimates,” “may,” and similar expressions) are forward-looking
statements. These statements include those pertaining to, among
other things, expectations related to Vitagraft, such as
the expectation for CMS coverage and reimbursement, the launch
of a FDA study over the next several quarters and eventual full
commercial launch, and other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by
management. Forward-looking statements involve risks and
uncertainties, including, without limitation, the potential impact
of COVID-19 on Oncocyte or its subsidiaries’ financial
and operational results, risks inherent in the development and/or
commercialization of diagnostic tests or products, uncertainty in
the results of clinical trials or regulatory approvals, the
capacity of Oncocyte’s third-party supplied blood sample analytic
system to provide consistent and precise analytic results on a
commercial scale, potential interruptions to supply chains, the
need and ability to obtain future capital, maintenance of
intellectual property rights in all applicable jurisdictions,
obligations to third parties with respect to licensed or acquired
technology and products, the need to obtain third party
reimbursement for patients’ use of any diagnostic
tests Oncocyte or its subsidiaries commercialize in
applicable jurisdictions, and risks inherent in strategic
transactions such as the potential failure to realize anticipated
benefits, legal, regulatory or political changes in the applicable
jurisdictions, accounting and quality controls, potential greater
than estimated allocations of resources to develop and
commercialize technologies, or potential failure to maintain any
laboratory accreditation or certification. Actual results may
differ materially from the results anticipated in these
forward-looking statements and accordingly such statements should
be evaluated together with the many uncertainties that affect the
business of Oncocyte, particularly those mentioned in the
“Risk Factors” and other cautionary statements found in
Oncocyte’s Securities and Exchange Commission (SEC)
filings, which are available from the SEC’s website. You are
cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date on which they were
made. Oncocyte undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made, except as required by
law.
Investor & Media ContactCaroline CornerICR
Westwicke Tel:
415.202.5678caroline.corner@westwicke.com
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