Adaptive Biotechnologies (ADPT) Receives Updated Medicare Coverage for clonoSEQ

November 12, 2021 5:32 AM EST

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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, announced that Palmetto GBA’s Molecular Diagnostics Program (MolDX) has finalized a local coverage determination (LCD) which supports the Medicare coverage for clonoSEQ® to detect and monitor minimal residual disease (MRD) in patients with B-cell acute lymphoblastic leukemia (ALL), multiple myeloma (MM) and chronic lymphocytic leukemia (CLL).

“We are pleased that MolDX finalized the LCD for next-generation sequencing (NGS) tests for MRD, solidifying patient access to the critical results that our clonoSEQ Assay provides across the continuum of care,” said Lance Baldo, MD, Chief Medical Officer of Adaptive Biotechnologies. “This LCD provides a pathway for the continued expansion of clonoSEQ into routine clinical care to benefit the more than 700,000 patients living with lymphoid malignancies in the United States.1 We look forward to our continued work with Medicare to help evolve coverage within this rapidly advancing field.”

The final LCD is consistent with the draft posted by Medicare in September of 2020, which established coverage of MRD as a “series of assays” in a patient with cancer and outlined specific coverage criteria for MRD tests. The LCD states that MRD testing for cancer is a sensitive and specific way to measure relative amounts of cancer cells in the body and has demonstrated its ability to impact patient care. The LCD also mentions that MRD assessment with clonoSEQ in lymphoid cancers, including ALL, MM and CLL, is a well-established tool for physicians.

clonoSEQ is the first and only U.S. Food and Drug Administration (FDA)-cleared assay for MRD assessment in CLL, MM and ALL, and is widely available to clinicians and patients across the U.S. clonoSEQ leverages the power of NGS and offers an accurate and reliable way to assess how disease burden changes over time in response to treatment or during remission. When utilized as a series of tests throughout a patient’s journey with cancer, the assay can help clinicians predict long-term outcomes, assess treatment response, monitor disease burden and detect potential relapse. clonoSEQ has broad coverage in the U.S., with over 240 million covered lives across both Medicare and commercial payers.

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