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In Brief This Week: Bio-Techne, Molecular Testing Labs

NEW YORK (360Dx) – Bio-Techne this week announced that the US Food and Drug Administration has granted Breakthrough Device designation for its ExoDx Prostate IntelliScore (EPI) test. The FDA designation validates the clinical importance of the EPI test and is intended to accelerate the regulatory review process, Bio-Techne said. The FDA 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 has received an Idaho Global Entrepreneurial Mission grant in partnership with Boise State University to advance 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.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.

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