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Adaptive Biotechnologies Receives Expanded FDA Clearance for the clonoSEQ® Assay to Assess Minimal Residual Disease (MRD) in Patients with Chronic Lymphocytic Leukemia
First and only FDA-cleared assay for MRD in CLL, multiple myeloma and ALLCLL clearance includes testing in blood; Adaptive collaborating with LabCorp® and
About this update from Adaptive Biotechnologies Corporation
[{"type":"text","content":"First and only FDA-cleared assay for MRD in CLL, multiple myeloma and ALLCLL clearance includes testing in blood; Adaptive collaborating with LabCorp® and Phlebotek Solutions® to provide clonoSEQ patients convenient options and safe access to blood draws at home or at LabCorp Patient Service Centers A Media Snippet accompanying this announcement is available by clicking on the image or link below:\n Adaptive Biotechnologies Receives Expanded FDA Clearance for the clonoSEQ® Assay to Assess Minimal Residual Disease (MRD) in Patients with Chronic Lymphocytic Leukemia: Media Snippet SEATTLE, Aug. 06, 2020 (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, today received clearance from the U.S. Food and Drug Administration (FDA) for its clonoSEQ® Assay to detect and monitor minimal residual disease (MRD) in blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ is the first and only FDA-cleared in vitro diagnostic for MRD monitoring in CLL. Today’s clearance expands the existing FDA-cleared uses of clonoSEQ, as the FDA previously granted the assay De Novo designation for the detection and monitoring of MRD in bone marrow from multiple myeloma and B-cell acute lymphoblastic leukemia (ALL) patients. Access to clonoSEQ for CLL patients nationwide is supported by the already-established Medicare coverage of clonoSEQ in CLL, as well as by the FDA’s clearance of clonoSEQ testing for CLL patients in blood and marrow. Medicare coverage is critically important in CLL, as nearly 80 percent of patients living with CLL in the U.S. are of Medicare age. clonoSEQ’s ability to detect MRD in blood provides CLL patients and health care providers with a more convenient and less intrusive option to monitor disease burden. “FDA clearance of clonoSEQ, which can detect one single cancer cell among a million healthy cells, is an important milestone for the CLL community,” said Dr. Brian Koffman, Chief Medical Officer and EVP of the CLL Society, Inc. “Looking with greater accuracy for persistent cancer cells can show how well treatment is working and may help inform important decisions such as changing or stopping therapy. In my own CLL journey, kno...