Genetron Holdings Limited (“Genetron Health” or the “Company”, Nasdaq: GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, today announced that its blood-based next-generation sequencing (NGS) test, HCCscreenTM, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). Based on the correspondence with Center for Devices and Radiological Health (CDRH) of the FDA, HCCscreenTM is intended for early detection of hepatocellular carcinoma in individuals who are designated to be at high-risk for HCC due to chronic HBV infection and/or liver cirrhosis.
Genetron Health intends to develop HCCscreenTM as an NGS-based product in the US. 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. In China, HCCscreenTM has recently been commercialized as a lab developed test (LDT).
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