On June 20, 2019 Adaptive Biotechnologies reported 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 (Press release, Adaptive Biotechnologies, JUN 20, 2019, View Source [SID1234537199]). 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.
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"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.