Posted by Michael Wonder on 01 Oct 2020
Genetron Health receives U.S. FDA breakthrough device designation for its blood based NGS test for early detection of hepatocellular carcinoma
30 September 2020 - Genetron Holdings today announced that its blood-based next-generation sequencing test, HCCscreen, has been granted breakthrough device designation by the U.S. FDA.
Based on the correspondence with Center for Devices and Radiological Health of the FDA, HCCscreen 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’s HCCscreen was granted based on its superior clinical performance over the current standard of care (i.e., ultrasound plus alfa fetoprotein) in a prospective clinical study. With this designation, the Company will have an opportunity to interact with the FDA's experts to efficiently address topics through the pre-submission process, so as to receive feedback from the FDA and identify areas of agreement in a timely way. It also allows priority review upon pre-market approval submission, and Medicare coverage by the CMS upon formal approval.
