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Adaptive Biotechnologies ClonoSeq With IGHV Mutation Status

Adaptive Biotechnologies has launched an enhanced version of its ClonoSeq B-cell Clonality (ID) report, which will now feature the immunoglobulin heavy chain – V mutation status for patients with chronic lymphocytic leukemia. ClonoSeq is the first and only in vitro diagnostic cleared by the US Food and Drug Administration to detect and monitor minimal residual disease in blood or bone marrow from patients with CLL. Moving forward, all ClonoSeq B-cell Clonality (ID) reports will automatically include IGHV mutation status, which has been shown to be prognostic of outcomes. Guidelines from both the National Comprehensive Cancer Network and the International Workshop on Chronic Lymphocytic Leukemia recommend testing for the IGHV mutation in the upfront evaluation of newly diagnosed CLL patients.

Although ClonoSeq is FDA-approved, the IGHV mutation status aspect of the assay is being offered as a CLIA-validated lab-developed test.