clonoSEQ Assay Medicare Coverage Expanded to Include MRD in CLL

January 14, 2020
Maggie L. Shaw

clonoSEQ, from Adaptive Biotechnologies, is a next-generation sequencing assay with existing Medicare coverage to monitor for minimal residual disease (MRD) in multiple myeloma and B-cell acute lymphoblastic leukemia. The newest Medicare coverage is for chronic lymphocytic leukemia (CLL), which takes effect immediately.

clonoSEQ, from Adaptive Biotechnologies, is a next-generation sequencing assay that uses a proprietary immunosequencing platform to monitor for minimal residual disease (MRD) in multiple myeloma and B-cell acute lymphoblastic leukemia—coverage it received last year. The newest Medicare coverage is for chronic lymphocytic leukemia (CLL), meaning that clonoSEQ is now available to more than 175 million individuals with healthcare coverage under Medicare or privately.

The expanded CLL Medicare coverage takes effect immediately and was handed down after clonoSEQ was evaluated for this indication by Palmetto GBA, a Medicare Administrative Contractor that reviews the utility of diagnostic technologies for Medicare coverage.

With trial results stressing the importance of MRD in predicting long-term patient outcomes—as well as abstracts presented at this year’s American Society of Hematology Annual Meeting—the implications of clonoSEQ’s expanded coverage could be far-reaching, most notably because MRD assessment is actually a series of tests that monitor for any signs of remission, relapse, and treatment response. The results also help to determine patient care.

“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,” stated Javier Pinilla-Ibarz, MD, PhD, senior member and head of the Lymphoma Program in the Department of Malignant Hematology at Moffit Cancer Center.

clonoSEQ is the only FDA-authorized MRD test for use in any lymphoid malignancy.

Reference

Adaptive Biotechnologies receives expanded Medicare coverage of clonoSEQ for monitoring MRD in patients with chronic lymphocytic leukemia [news release]. Seattle, WA: Adaptive Biotechnologies; January 8, 2020. investors.adaptivebiotech.com/news-releases/news-release-details/adaptive-biotechnologies-receives-expanded-medicare-coverage. Accessed January 13, 2020.