The FDA designates Exact Sciences’ (EXAS +0.9%) hepatocellular carcinoma (HCC) test a Breakthrough Device. The status, akin to Breakthrough Therapy for a drug, provides for more intensive guidance on development by the FDA, the involvement of more senior agency personnel and priority review of the marketing application.
Data being presented at The Liver Meeting in Boston this weekend showed 80% sensitivity (detecting true positives) and 90% specificity (detecting true negatives) for a novel combination of six blood-based biomarkers for HCC and 71% sensitivity/90% specificity for early-stage HCC.
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