Adaptive Biotechnologies Receives Expanded Medicare Coverage of clonoSEQ® for Assessing Measurable Residual Disease in Mantle Cell Lymphoma

Core Insights - Adaptive Biotechnologies Corporation announced that clonoSEQ is now covered by Medicare for measurable residual disease (MRD) assessment in patients with mantle cell lymphoma (MCL) [1][4] Group 1: Company Overview - Adaptive Biotechnologies is a commercial-stage biotechnology company focused on translating the genetics of the adaptive immune system into clinical products for disease diagnosis and treatment [9] - The company leverages its proprietary immune medicine platform to identify and quantify specific DNA sequences in malignant cells, enabling clinicians to assess and monitor MRD [7] Group 2: Product Details - clonoSEQ is the first and only FDA-cleared in vitro diagnostic test for detecting MRD in various hematologic malignancies, including MCL, multiple myeloma, chronic lymphocytic leukemia, and B-cell acute lymphoblastic leukemia [6][7] - The updated Medicare coverage policy allows for clonoSEQ MRD testing for all MCL patients, regardless of their treatment regimen, significantly expanding access for the Medicare population [4][5] Group 3: Market Context - MCL has an annual incidence of approximately 4,000 cases in the U.S., and patients often experience multiple relapses, highlighting the need for effective monitoring tools [2][3] - The clonoSEQ test provides a minimally invasive, blood-based option for assessing treatment response and monitoring for recurrence, which is critical given the aggressive nature of MCL [3][4]