Adaptive Biotechnologies, a biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, has 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), according to a press release from the company. The same release points out clonoSEQ is the first and only FDA-cleared in vitro diagnostic for MRD monitoring in CLL.
The assay 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 healthcare providers with a more convenient and less intrusive option to monitor disease burden.
The availability of clonoSEQ testing in blood will facilitate ease of testing for CLL patients, but as the COVID-19 pandemic continues, some patients may be unable to or may feel anxious about obtaining a blood draw in a hospital or clinic. To address this, Adaptive has launched a service offering which will enable clonoSEQ patients to safely obtain blood draws in alternate settings. Patients can either access minimal-contact blood collection services at any LabCorp Patient Service Centers in the U.S., or they can have a blood draw performed by a qualified professional in the comfort of their own homes through Adaptive’s collaboration with Phlebotek Solutions, a nationwide provider of mobile phlebotomy services.
