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Adaptive Biotechnologies Gains Expanded Medicare Coverage for ClonoSeq

NEW YORK – Adaptive Biotechnologies announced Wednesday that Medicare contractor Palmetto has expanded coverage for Adaptive's ClonoSeq assay to include minimal residual disease monitoring in patients with chronic lymphocytic leukemia (CLL.) The expansion adds to existing coverage for B cell acute lymphoblastic leukemia and multiple myeloma, which was established in January 2019. 

The expanded coverage policy is effective immediately, the firm said in a statement.

"Data are mounting to support the clinical benefits of MRD measurement in lymphomas and leukemias, including CLL, to help assess a patient's prognosis, measure response to therapy and inform treatment decisions," Lance Baldo, Adaptive CMO, said in a statement. "The Medicare coverage expansion validates this growing body of evidence and provides patients living with CLL greater access to highly sensitive, standardized MRD testing."

The US Food and Drug Administration has authorized the next-generation sequencing-based ClonoSeq assay to detect and monitor minimal residual disease in any lymphoid cancer.

"As newer therapies emerge for CLL that can help patients achieve very deep remissions, assessment of MRD can help guide clinical care by determining a patient's response to therapy and informing that patient's prognosis," Javier Pinilla-Ibarz, head of the lymphoma program at Moffit Cancer Center, said in a statement.