SEATTLE--(BUSINESS WIRE)--Adaptive Biotechnologies today announced that it has secured contractual agreements or positive medical policies for the clonoSEQ® Assay with several of the largest national private health insurers in the United States, as well as significant regional coverage, bringing the total number of covered lives to more than 140 million. The agreements and medical policies expand access to clonoSEQ for minimal residual disease (MRD) testing in patients with lymphoid cancers. clonoSEQ is the first and only FDA-cleared test for assessing and monitoring MRD in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL), helping to track a patient’s cancer and inform treatment decisions. clonoSEQ announced Medicare coverage in January 2019, and private insurer access has steadily increased in the first half of 2019. Coverage of clonoSEQ testing is generally consistent with the assay’s FDA label and includes assessment of MRD at multiple time points throughout therapy to monitor treatment responses and help predict outcomes in patients with MM and ALL.
“There are over 600,000 patients living with lymphoid blood cancers in the United States alone. As patients are living longer than ever before due to new therapies, clinicians need a better tool to monitor disease burden and treatment response on a regular basis,” said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. “This positive momentum provides patients with a standardized, accurate and sensitive tool to inform personalized treatment decisions. We look forward to continuing to work with payors around the country to ensure patients in need have access to clonoSEQ.”
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 biotech 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 unprecedented 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.
This press release contains forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Company’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, development plans, preclinical and clinical results and other future conditions. All statements, other than statements of historical fact, contained in this press release are forward looking statements, including statements regarding our ability to expand or maintain payor reimbursement coverage; our future financial or business performance, conditions, plans, prospects, trends or strategies and other financial and business matters; and the availability of alternative diagnostic tests in our target market. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Actual results may differ materially from those expressed in our forward-looking statements due to any number of risks and uncertainties, including those summarized in documents filed with the Securities and Exchange Commission. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, the Company does not plan to publicly update or revise any forward-looking statements contained herein.