GTH - Genetron Health +8% on Breakthrough Device tag for HCCscreen

Genetron Holdings' (GTH) blood-based next-generation sequencing ((NGS)) test, HCCscreen, has been granted Breakthrough Device designation by the FDA.HCCscreen is intended for early detection of hepatocellular carcinoma in individuals who are designated to be at high-risk due to chronic HBV infection and/or liver cirrhosis.The designation, akin to Breakthrough Therapy status for a drug, provides for more intensive guidance on development by the FDA, the involvement of more senior agency personnel, the assignment of a case manager and priority review of the marketing application. The company is also building a lab in Maryland, which it intends to seek CLIA certification, to serve global pharmaceutical companies on R&D and commercialization.Shares are up 8% premarket.

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Genetron Health +8% on Breakthrough Device tag for HCCscreen