Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial
stage biotechnology company that aims to translate the genetics of
the adaptive immune system into clinical products to diagnose and
treat disease, today announced an expansion of its collaboration
with Labcorp (NYSE:LH), a leading global life sciences company, to
enable broader access to Adaptive’s growing portfolio of
immune-driven clinical diagnostic and research products. The
expanded collaboration includes a commercial agreement for
Adaptive’s clonoSEQ® and immunoSEQ® assays and a lab services
agreement for Adaptive’s recently launched T-Detect COVID™ test,
the first clinical T-cell based test for patients to confirm recent
or prior COVID-19 infection.
The collaboration builds on the parties’ initial agreement
signed in May 2020 to provide safe blood collection services at
nearly 2,000 Labcorp patient service centers (PSCs) for patients
using clonoSEQ, the first and only FDA-cleared assay for minimal
residual disease (MRD) in select blood cancers. As part of the
companies’ deeper collaboration, patients can now have convenient
blood collection for both the clonoSEQ and T-Detect™ COVID tests at
any Labcorp PSC.
“We are proud to partner with Labcorp to expand patient access
to blood draws necessary for novel tests like clonoSEQ and
T-Detect,” said Chad Robins, co-founder and chief executive officer
of Adaptive. “By providing patients with easy and safe ways to
access critical health services, especially during this difficult
time, we can expand the impact we can have on patients impacted by
blood cancers, COVID-19, and eventually many other immune-mediated
diseases.”
The two companies will work closely together to expand the
commercial reach of clonoSEQ and operational capacity for T-Detect
COVID. Labcorp’s oncology sales force will promote clonoSEQ at
hematology-oncology clinics in the U.S. In addition, Labcorp is
preparing to perform T-Detect COVID as a secondary site laboratory
once the test has received Emergency Use Authorization (EUA) from
the U.S. Food and Drug Administration (FDA).
In addition, Labcorp will expand its immunosequencing portfolio
by offering its biopharmaceutical customers the immunoSEQ and
immunoSEQ® T-MAP™ COVID assays using Research Use Only (RUO) test
kits.
“By expanding access to Adaptive’s growing portfolio of clinical
and research products, Labcorp is helping to guide patient care
decisions during a time when access to healthcare is challenging,”
said Brian Caveney, M.D., chief medical officer and president of
Labcorp Diagnostics. “We are thrilled to deepen our commercial
collaborations in multiple therapeutic areas across both drug
development and clinical diagnostics with innovative,
science-driven companies like Adaptive.”
About T-Detect™T-Detect™ is a highly
sensitive and specific diagnostic test under development for
multiple diseases, translating the natural diagnostic capability of
T cells into clinical practice. In 2018, Adaptive and Microsoft
partnered to build a map of the immune system called the
TCR-Antigen Map. This approach uses immunosequencing, proprietary
computational modeling, and machine learning to map T-cell receptor
sequences to disease-associated antigens for infectious diseases,
autoimmune disorders and cancer. From a simple blood draw, T-Detect
will leverage the map to provide an immunostatus for an individual,
enabling early disease diagnosis, disease monitoring, and critical
insights into immunity. T-Detect COVID is the first clinical test
launched from this collaboration and the first commercially
available T-cell test designed to detect recent or prior SARS-CoV-2
infections. T-Detect COVID is an in vitro diagnostic that is
available for prescription use only. This test has not been cleared
or approved by the FDA and is available for use as a CLIA-validated
laboratory developed test. T-Detect COVID is not indicated for use
in patients under age 18.
About the clonoSEQ(R)
AssayThe clonoSEQ Assay is the first and only
FDA-cleared assay for MRD in chronic lymphocytic leukemia (CLL),
multiple myeloma (MM) and B-cell acute lymphoblastic leukemia
(ALL). Minimal residual disease (MRD) refers to the small number of
cancer cells that can stay in the body during and after treatment.
clonoSEQ was initially granted De Novo designation and marketing
authorization by the FDA for the detection and monitoring of MRD in
patients with MM and B-ALL using DNA from bone marrow
samples. In August 2020, clonoSEQ received additional
clearance from the FDA to detect and monitor MRD in blood or
bone marrow from patients with CLL.
The clonoSEQ Assay leverages Adaptive’s proprietary immune
medicine platform to identify and quantify specific DNA sequences
found in malignant cells, allowing clinicians to assess and monitor
MRD during and after treatment. The assay provides standardized,
accurate and sensitive measurement of MRD that allows physicians to
predict patient outcomes, assess response to therapy over time,
monitor patients during remission and predict potential relapse.
Clinical practice guidelines in hematological malignancies
recognize that MRD status is a reliable indicator of clinical
outcomes and response to therapy, and clinical outcomes have been
shown to be strongly associated with MRD levels measured by the
clonoSEQ Assay in patients diagnosed with CLL, MM and
ALL.
The clonoSEQ Assay is a single-site test performed at Adaptive
Biotechnologies. In addition to its FDA-cleared uses, clonoSEQ
is also available as a CLIA-validated laboratory developed test
(LDT) service for use in other lymphoid cancers and sample
types. For important information about the FDA-cleared uses
of clonoSEQ, including the full intended use, limitations, and
detailed performance characteristics, please
visit www.clonoSEQ.com/technical-summary.
About the immunoSEQ®
AssayThe immunoSEQ Assay is the industry gold
standard in immunosequencing and helps researchers make discoveries
in areas such as oncology, autoimmune disorders, infectious
diseases, neurobiology, transplant, and basic immunology. The
immunoSEQ® Technology is a quantitative and sensitive
immunosequencing solution for academic researchers and
pharmaceutical companies to understand the immune response to
diseases and therapeutics by sequencing the DNA of immune receptors
at high throughput scale. The immunoSEQ® T-MAP™
COVID offering is the first and only service of its kind to
accurately and reproducibly assess the T-cell immune response to
COVID-19 vaccines in development and longitudinally track the
persistence of that response over time.
The immunoSEQ Assay can identify millions of T- and B-cell
receptors from a single sample in exquisite detail. Offered as a
Service or Kit, the immunoSEQ Assay is used to ask and answer
translational research questions and discover new prognostic and
relevant signals in clinical research. The immunoSEQ Assay provides
quantitative, scalable, and reproducible sequencing results along
with access to a powerful, easy-to-use analysis tools via the
immunoSEQ® Analyzer software. The immunoSEQ Assay is for research
use only and is not for use in diagnostic procedures. For more
information visit us at www.immunoseq.com
About LabcorpLabcorp is a leading global life
sciences company that provides vital information to help doctors,
hospitals, pharmaceutical companies, researchers, and patients make
clear and confident decisions. Through our unparalleled diagnostics
and drug development capabilities, we provide insights and
accelerate innovations to improve health and improve lives.
With more than 75,000 employees, we serve clients in more than 100
countries. Labcorp (NYSE: LH) reported revenue of $14 billion in
FY2020. Learn more about us at www.Labcorp.com or follow
us on LinkedIn and Twitter @Labcorp.
About Adaptive Adaptive Biotechnologies is
a commercial-stage biotechnology company focused on harnessing the
inherent biology of the adaptive immune system to transform the
diagnosis and treatment of disease. We believe the adaptive immune
system is nature’s most finely tuned diagnostic and therapeutic for
most diseases, but the inability to decode it has prevented the
medical community from fully leveraging its capabilities. Our
proprietary immune medicine platform reveals and translates the
massive genetics of the adaptive immune system with scale,
precision and speed to develop products in life sciences research,
clinical diagnostics, and drug discovery. We have three commercial
products, and a robust clinical pipeline to diagnose, monitor and
enable the treatment of diseases such as cancer, autoimmune
conditions and infectious diseases. Our goal is to develop and
commercialize immune-driven clinical products tailored to each
individual patient. For more information, please visit
adaptivebiotech.com and follow us on
www.twitter.com/adaptivebiotech.
Adaptive Biotechnologies Forward Looking
StatementsThis press release contains forward-looking
statements that are based on Adaptive Biotechnologies’ management’s
beliefs and assumptions and on information currently available to
management. All statements contained in this release other than
statements of historical fact are forward-looking
statements. These statements involve risks, uncertainties and
other factors that may cause actual results, levels of activity,
performance or achievements to be materially different from the
information expressed or implied by these forward-looking
statements. These risks, uncertainties and other factors are
described under "Risk Factors," "Management's Discussion and
Analysis of Financial Condition and Results of Operations" and
elsewhere in the documents we file with the Securities and Exchange
Commission from time to time. We caution you that forward-looking
statements are based on a combination of facts and factors
currently known by us and our projections of the future, about
which we cannot be certain. As a result, the forward-looking
statements may not prove to be accurate. The forward-looking
statements in this press release represent our views as of the date
hereof. We undertake no obligation to update any forward-looking
statements for any reason, except as required by law.
ADAPTIVE MEDIABeth
Keshishian917-912-7195media@adaptivebiotech.com
ADAPTIVE INVESTORSKarina Calzadilla, Vice
President, Investor Relations201-396-1687Carrie
Mendivil, Gilmartin Groupinvestors@adaptivebiotech.com
LABCORP CONTACTS: Media: Christopher
Allman-Bradshaw336-436-8263Media@Labcorp.com
Investors: Chas Cook336-436-5076Investor@Labcorp.com
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