NEW YORK (GenomeWeb) – Adaptive Biotechnologies announced this week that it has signed agreements or received positive medical coverage decisions for its ClonoSeq Assay with several large national and regional health insurers in the US, bringing the total number of covered lives to more than 140 million. The agreements and medical policies expand access to ClonoSeq for minimal residual disease (MRD) testing in patients with lymphoid cancers. The assay is FDA-cleared test assessing and monitoring MRD in patients with multiple myeloma and B-cell acute lymphoblastic leukemia, Adaptive said.
Bio-Techne this week announced that the US Food and Drug Administration has granted Breakthrough Device designation to its ExoDx Prostate IntelliScore (EPI) test, making it the first exosome-based liquid biopsy test to receive the designation. The FDA designation validates the clinical importance of the EPI test and is intended to accelerate the regulatory review process, Bio-Techne said.
The designation comes on the heels of the firm receiving a clinical laboratory permit from the New York State Department of Health to provide its EPI test in the state.
Molecular Testing Labs said this week that it has received an Idaho Global Entrepreneurial Mission grant in partnership with Boise State University to advance the partners' efforts to develop RNA tests for the early detection, monitoring, and treatment of HIV. Molecular Testing Labs specializes in sexually transmitted infection testing using dried blood spots, from which RNA can be extracted for detecting HIV as soon as one week after initial infection, the company said.
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