Adaptive Biotechnologies and Collaborators to Present Data from More Than 25 clonoSEQ® Abstracts at ASH 2019 Demonstrating Clinical Relevance of Standardized, Accurate MRD Testing for Blood Cancer Patients
Research and real-world evidence support the use across a range of leukemias and lymphomas and demonstrate utility in multiple tissue types, including blood and bone marrow
Late breaker presentation of CANDOR study includes secondary endpoint of improved NGS MRD negative Complete Response Rate at 12 monthsSEATTLE, Dec. 04, 2019 (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, and its collaborators will present data from more than 25 abstracts for Adaptive’s next-generation sequencing (NGS)-based clonoSEQ Assay at the 61st Annual Meeting of the American Society of Hematology (ASH) in Orlando, FL, December 7 – 10. clonoSEQ is the only FDA-cleared test to monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples.“An unprecedented amount of MRD data are being presented at the ASH annual meeting, demonstrating its established significance as a clinical trial endpoint and a validated measure of patient outcomes in select blood cancers,” said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. “The widespread use of clonoSEQ in clinical research and in patient care underscores the need for a highly sensitive, standardized test that gives patients, clinicians and drug developers confidence in their assessment of MRD status.”MRD is a measure of the amount of cancer in the body, specifically the very small number of cancer cells that remain during or after treatment. MRD testing is performed as a series of tests throughout a patient’s cancer journey to regularly inform treatment decisions. In addition to routine use of MRD as a key endpoint to measure response in research, MRD is being used as an endpoint in clinical trials, and now it is rapidly being incorporated into clinical practice. As MRD measurement continues to inform day-to-day clinical practice, real-world data mounts confirming the outcomes in established in research which includes the ability to assess prognosis, evaluate depth of response to therapy and monitor disease burden over time.clonoSEQ, the first clinical application of Adaptive’s immune medicine platform, will be featured in a late-breaker presentation, 9 oral presentations and more than 15 posters. Data on approved, investigational and research uses from studies and real-world experience will be presented across a range of cancers including multiple myeloma, ALL, CLL, and NHLs such as DLBCL, FL and MCL. These new data support the use of NGS MRD testing in multiple disease settings using both bone marrow and blood samples, as well as the important role of MRD monitoring in a real-world clinical setting. In addition, data will be presented demonstrating the utility of Adaptive’s immune profiling research tool, immunoSEQ® to quantitatively assess the immune response to novel therapies in development.Key presentations include:About the clonoSEQ AssayThe clonoSEQ Assay was granted de novo designation and marketing authorization by FDA for the detection and monitoring of minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples. clonoSEQ is the first and only FDA-authorized in vitro diagnostic assay for MRD testing. It is also the first clinical diagnostic powered by immunosequencing to receive FDA clearance. clonoSEQ leverages Adaptive’s proprietary immunosequencing 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 detect 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 are strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with ALL and MM. clonoSEQ testing is covered by Medicare and an expanding list of private payors in alignment with the FDA label.clonoSEQ is a single-site assay performed at Adaptive Biotechnologies. It is also available as a CLIA-regulated laboratory developed test (LDT) service for use in other lymphoid cancers. 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 immunoSEQ AssayAdaptive’s immunoSEQ Assay helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology. 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 diagnostic signals in clinical trials. The immunoSEQ Assay provides quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assay is for research use only and is not for use in diagnostic procedures.About Adaptive BiotechnologiesAdaptive 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 two 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.Forward Looking StatementsThis press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. 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We undertake no obligation to update any forward-looking statements for any reason, except as required by law.MEDIA CONTACT:
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