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Adaptive Biotechnologies Launches Enhanced clonoSEQ® Assay Reports for Patients with Chronic Lymphocytic Leukemia, Now Featuring IGHV Mutation Status
Combined ID-IGHV report at time of diagnosis conveniently provides additional prognostic information while also enabling future MRD monitoring in patients
About this update from Adaptive Biotechnologies Corporation
[{"type":"text","content":"Combined ID-IGHV report at time of diagnosis conveniently provides additional prognostic information while also enabling future MRD monitoring in patients\nSEATTLE, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, announced today 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 today, 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. “clonoSEQ is a tool I utilize often to assess MRD status in my patients that require time limited therapy for CLL, not only because it is valuable for helping predict potential relapse or survival but also because it informs my patient management,” said Javier Pinilla-Ibarz, MD, PhD, senior member and head of the Lymphoma Program in the Department of Malignant Hematology at Moffit Cancer Center. “Now that patients will also receive their IGHV mutation status through clonoSEQ testing, it will become an even more valuable diagnostic for hematologists to use at the start of patient workups, potentially saving patients both cost and time as there is onl...