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Medicare Expands Coverage for Adaptive Biotechnologies' clonoSEQ® MRD Test to Include Mantle Cell Lymphoma

NextEdge Admin

10 Nov 2024

2 min 22 sec

MRD Test,Mantle Cell Lymphoma,Medicare coverage

Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a biotechnology firm specializing in immune-genetics-based diagnostics, announced that Palmetto GBA, a Medicare Administrative Contractor, has expanded coverage for its clonoSEQ® test to include Medicare patients with mantle cell lymphoma (MCL). clonoSEQ detects measurable residual disease (MRD) — remaining cancer cells after treatment — which is crucial in monitoring the aggressive nature of MCL, a non-Hodgkin lymphoma subtype with around 4,000 cases per year in the U.S.

MCL is known for its variable disease course, with relapses ranging from shortly after initial treatment to many years later. By using clonoSEQ's blood-based MRD test, clinicians gain insights into a patient's response to therapy, potential relapse, and prognosis. The sensitivity of clonoSEQ allows for the early detection of molecular recurrence, complementing traditional monitoring tools like imaging.

Dr. Anita Kumar of Memorial Sloan Kettering Cancer Center emphasized the importance of MRD insights for improved patient outcomes in MCL. clonoSEQ now aligns with the Medicare episode payment structure, with the recent adjustment in pricing to $8,029 across covered indications, matching the Medicare-recommended gapfill rate.

Previously approved for multiple myeloma, chronic lymphocytic leukemia, and other blood cancers, clonoSEQ is available as an FDA-cleared test for multiple myeloma and B-cell acute lymphoblastic leukemia, and as a laboratory-developed test in other blood cancers. The expansion to MCL will enable more comprehensive, patient-centered care strategies and offer clinicians a more refined approach to monitoring disease progression and therapy effectiveness.