Received coveted FDA Breakthrough Device designation for its NGS test for early detection of hepatocellular carcinoma
Rockville, Md. — Citing proximity to leading U.S. regulators and researchers, fast-growing precision oncology company, Genetron Health Inc. (Genetron), is moving its U.S. headquarters to Montgomery County, Maryland from North Carolina’s Research Triangle. The China-based company is relocating to a 6,000 SF hybrid space for Research & Development and a state-of-the-art lab in Gaithersburg, Maryland for its planned rapid growth.
Genetron’s blood-based next generation sequencing (NGS) test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), designed for early detection of hepatocellular carcinoma due to chronic HBV infection and/or liver cirrhosis. Genetron believes they are one of the first China-based, cancer molecular diagnostic companies to receive this critical FDA designation.