Adaptive Biotechnologies Receives Expanded Medicare Coverage of clonoSEQ® for Surveillance in Mantle Cell Lymphoma

Core Insights - Adaptive Biotechnologies Corporation announced the expansion of Medicare coverage for clonoSEQ testing to include single time point testing for monitoring recurrence in mantle cell lymphoma (MCL) patients [1][2][3] Group 1: Coverage Expansion - The expanded coverage allows patients who have completed treatment to receive clonoSEQ testing every six months for up to five years during treatment-free remission, followed by annual testing until disease recurrence is detected [2][3] - This decision marks the first indication for clonoSEQ in MCL and aligns with the updated Clinical Laboratory Fee Schedule (CLFS) rate of $2,007 per test [2][3] Group 2: Clinical Significance - The coverage expansion is seen as a significant win for MCL patients, enabling better monitoring and management of those at risk of relapse [3] - MCL has an annual incidence of approximately 4,000 cases in the U.S., and ongoing monitoring is crucial due to the potential for relapse even years after initial remission [3][4] Group 3: clonoSEQ Testing Overview - clonoSEQ is the first FDA-cleared in vitro diagnostic test for detecting minimal residual disease (MRD) in various hematologic malignancies, including MCL [5][6] - The test leverages a proprietary immune medicine platform to provide accurate and sensitive MRD measurements, which are critical for predicting patient outcomes and guiding treatment decisions [6][9]