NEW YORK – Adaptive Biotechnologies said Thursday that Medicare contractor Palmetto GBA has expanded coverage of the company's ClonoSeq assay to include minimal residual disease monitoring in patients with diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma.
DLBCL joins several other disease settings where ClonoSeq — a next-generation sequencing assay that assesses the clonal landscape of circulating blood cells — is already covered by Medicare, including multiple myeloma, chronic lymphocytic leukemia, and B-cell acute lymphoblastic leukemia.
Adaptive said the coverage determination is also the first for ClonoSeq to include the assessment of MRD based on circulating tumor DNA. In DLBCL, ctDNA aids the identification of patients at high risk for recurrence and provides oncologists with information to create a more precise, personalized treatment plan.
"We've advanced therapy for large B-cell lymphomas significantly in recent years; however, a considerable unmet need for highly specific, precise monitoring of disease progression during and after treatment remains," Moffitt Cancer Center oncologist Frederick Locke said in a statement.
"We believe ClonoSeq raises the bar for disease monitoring in DLBCL patients. Recent studies have shown that MRD assessment with ClonoSeq early post-CAR-T treatment can be more informative than PET-CT in identifying patients who were at high risk for relapse," Adaptive Chief Commercial Officer Nitin Sood said in a statement.
According to Adaptive, over 75 percent of actively treated DLBCL patients are Medicare aged. The new policy is effective immediately and applies to all DLBCL patients, regardless of line of therapy, treatment regimen, or testing time point.