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Medicare Covers Adaptive Biotechnologies' ClonoSeq Assay

NEW YORK (GenomeWeb) – Adaptive Biotechnologies said after the close of the market on Thursday that Medicare contractor Palmetto GBA has established coverage of its next-generation sequencing-based assay, ClonoSeq, for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia.

The US Food and Drug Administration granted de novo premarket authorization to ClonoSeq last year to detect and monitor minimal residual disease by sequencing DNA from bone marrow of patients with some blood cancers.

The coverage is effective immediately. Another Medicare contractor, Noridian, also is covering ClonoSeq, Adaptive said.

"Availability of sensitive, specific, and standardized MRD testing is increasingly crucial to the delivery of optimal patient care in both multiple myeloma and ALL," Nikhil Munshi, director of basic and correlative science at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, said in a statement. "Medicare coverage for the ClonoSeq assay will help ensure that eligible patients across the US have access to a highly advanced option for MRD assessment to support more personalized treatment decisions across their course of care."

Charles Sang, Adaptive's senior vice president of diagnostics, said that the establishment of Medicare coverage "demonstrates the clinical relevance of MRD assessment and underscores the benefit that this test delivers in the management of myeloma and ALL patients."