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SEATTLE, Sept. 17, 2019 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq:ADPT) today announced it has entered into a global agreement with Amgen for the use of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® Assay to assess minimal residual disease (MRD) across multiple drug development programs within the Amgen hematology portfolio. Under the terms of the four-year agreement, Adaptive will receive annual development fees in addition to sequencing payments and regulatory milestones in exchange for providing MRD testing and analysis for ongoing and future clinical trials.
“We are excited to continue working with Amgen as their preferred partner to support the development and regulatory approval of novel blood cancer treatments,” said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. “This pan-portfolio partnership reflects Amgen’s confidence in the role that standardized NGS MRD testing with clonoSEQ plays in demonstrating drug efficacy in clinical trials and in day-to-day patient management.”
The partnership, which began in 2016 to assess MRD in acute lymphoblastic leukemia, demonstrates the increasing utility of MRD assessment in the clinic. Adaptive will leverage data generated under this partnership to continue building robust evidence that supports MRD as a validated measure of patient outcomes across multiple novel treatments and blood cancers.
"It is critical to know a patient’s MRD status because treating to MRD negativity has been shown to drive better clinical outcomes for patients in a variety of blood cancers," said Gregory Friberg, M.D., vice president of global development at Amgen. “Standardized, highly sensitive, molecular detection of MRD using clonoSEQ supports the development of potential cancer therapies that can help patients with blood cancer live longer.”
About the clonoSEQ Assay
The 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 Adaptive Biotechnologies
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 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 Statements
This press release contains forward-looking statements that are based on 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, including statements regarding Adaptive Biotechnologies’ partnership with Amgen, ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words “may,” “will,” “expect,” “plan,” “believe,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. 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 the Company files with the Securities and Exchange Commission (the "SEC") 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.
Director, Corporate Communications
Lynn Lewis or Carrie Mendivil