SEATTLE, Feb. 23, 2021 (GLOBE NEWSWIRE) -- 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.”
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) Assay
The 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® Assay
The 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
Labcorp 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.
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 Statements
This 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.
Karina Calzadilla, Vice President, Investor Relations
Carrie Mendivil, Gilmartin Group
Media: Christopher Allman-Bradshaw
Investors: Chas Cook