Genetron Health Receives U.S. FDA Breakthrough Device Designation for its Blood-based NGS Test for Early Detection of Hepatocellular Carcinoma

Designation represents Genetron Health’s first step to potentially expand the geographical reach of HCCscreen

BEIJING and GAITHERSBURG, Md., Sept. 30, 2020 (GLOBE NEWSWIRE) -- 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, HCCscreen^TM, 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, HCCscreen^TM 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.

Under the FDA’s Breakthrough Devices Program, the Breakthrough Device designation is granted for products that have the potential to offer more effective diagnosis of life-threatening diseases with an unmet medical need. The program is designed to speed up development, assessment and review processes, in order to provide patients with quicker access to those devices. Genetron Health’s HCCscreen^TM was granted based on its superior clinical performance over the current standard of care (i.e., ultrasound plus alpha-fetoprotein (AFP)) 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 premarket approval (PMA) submission, and Medicare coverage by the CMS (Center for Medicare and Medicaid Services) upon formal approval.

Genetron Health intends to develop HCCscreen^TM 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, HCCscreen^TM has recently been commercialized as a lab developed test (LDT). The Company has five laboratories in China, of which the Beijing lab is one of the few domestic labs that are both CAP and CLIA certified.