Adaptive Biotechnologies Corporation announced the launch of an enhanced version of its clonoSEQ® B-cell Clonality (ID) report, which will now feature the immunoglobulin heavy chain (IgH) – V mutation status for patients with chronic lymphocytic leukemia (CLL). clonoSEQ is the first and only in vitro diagnostic cleared by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease (MRD) in blood or bone marrow from patients with CLL. Starting Sept. 30, 2021, all clonoSEQ B-cell Clonality (ID) reports will automatically include IGHV mutation status. IGHV mutation status has been shown to be prognostic of outcomes in CLL, with mutated IGHV genes inferring better outcomes. Guidelines from both the National Comprehensive Cancer Network (NCCN) and the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) recommend testing for the IGHV mutation in the upfront evaluation of newly diagnosed CLL patients. Adding this feature to the clonoSEQ Assay will enable physicians to assess both IGHV status and MRD status with just one assay. Performing clonality (ID) assessment at time of diagnosis is an important step to establish patient-specific sequences to track for subsequent MRD monitoring, and studies have demonstrated that trackable sequences can be found in more than 95% of CLL patients. MRD describes the small number of cancer cells that remain in the body during and after treatment. MRD assessment with clonoSEQ is performed as a series of tests throughout a patient’s cancer journey to evaluate prognosis, determine response to treatment, monitor disease during remission and detect potential relapse. Evidence generated in CLL clinical trials (as well as other blood cancers) have shown that even the smallest amounts of residual disease can predict a patient’s long-term clinical outcomes. The test for IGHV mutation status is a CLIA-validated lab-developed test (LDT) and an additional feature of the clonoSEQ assay provided at the time of diagnosis. clonoSEQ IGHV mutation status is not FDA cleared or approved. Access to clonoSEQ for CLL patients nationwide is supported by the already-established Medicare coverage of clonoSEQ in CLL.