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Genetron Receives FDA Breakthrough Approval for Hepatocellular Carcinoma Detection Device

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Genetron Holdings Ltd. shares traded 25% higher after the company reported it has received Breakthrough Device Designation from the FDA for its blood-based next-generation sequencing test for early hepatocellular carcinoma detection.

Precision oncology platform company Genetron Holdings Ltd. (GTH:NASDAQ), which provides companion diagnostics development, early cancer screening products and molecular profiling tests, 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)."

The firm stated that it has been working closely with the Center for Devices and Radiological Health (CDRH) of the FDA and that "HCCscreenTM is intended for early detection of hepatocellular carcinoma (HCC) in individuals who are designated to be at high-risk for HCC due to chronic HBV infection and/or liver cirrhosis."

The company advised that HCCscreen was granted Breakthrough Device status based upon superior results observed in clinical performance compared to the existing standard of care in a prospective clinical study. The firm indicated that this designation will help to fast-track discussions with the FDA and will additionally provide the opportunity for priority review upon premarket approval (PMA) submission, and Medicare coverage by the Center for Medicare and Medicaid Services (CMS) upon formal approval.

The firm stated that it is presently building a laboratory facility in Maryland with the intention of developing HCCscreen as an NGS-based product in the U.S. The company plans to acquire CLIA certification for this new center, which it said will offer R&D and commercialization services to global pharmaceutical companies. Genetron noted that HCCscreen has recently been commercialized as a lab developed test (LDT) in China where the company already has five operating laboratories including a lab in Beijing that is one of only a few CAP and CLIA certified labs in the country.

The company explained that "HCCscreenTM is powered by Genetron Health's innovative and proprietary Mutation CapsuleTM technology, which enables detection of multiple methylation alterations in parallel with mutations in cell-free DNA from peripheral blood specimens."

The firm reported that HCCscreenTM is presently being tested in its ongoing clinical trial of 4,500 HBsAg+ patients of which 2,000 have already completed the study. The company released some preliminary data from 297 patients at one center that demonstrated positive results and expects to report the full data set in H1/21 for all of the first 2,000 participants who have completed the study.

The company pointed out that liver cancer is the fourth most common cause of cancer-related death globally and the sixth in terms of incidence and that almost half of the global incidences occur in China.

Genetron Health's co-founder and CEO Sizhen Wang remarked, "We are very pleased with the FDA's recognition of HCCscreenTM's potential as a more effective test for early detection of hepatocellular carcinoma. This designation also represents a significant milestone for our plan to expand HCCscreenTM's geographical reach. Hepatocellular carcinoma is one of the leading causes of cancer deaths globally, and an accurate, easy to use, blood-based early screening test would offer tremendous clinical value...Our HCCscreenTM asset has shown promising preliminary data in all key metrics including sensitivity, specificity, and positive predictive value. Notably, most of the confirmed HCC patients in the study had tumor sizes below five centimeters. This level of performance is highly encouraging as detecting tumor presence while they are small allows effective early interventions, which could lead to better outcomes."

Genetron Holdings Ltd. is headquartered in Beijing and described itself as "a leading precision oncology platform company that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment." The firm' oncology portfolio covers the areas of early screening, diagnosis and treatment, continuous disease monitoring and care cancer management. Genetron conducts business primarily within the domestic Chinese market and is now building a research facility in Gaithersburg, Md.

Genetron began the day with a market capitalization of around $857.1 million with approximately 88.36 million shares outstanding. GTH shares opened 5% higher today at $10.20 (+$0.50, +5.15%) over yesterday's $9.70 closing price. The stock has traded today between $10.20 and $14.245 per share and is currently trading at $12.20 (+$2.50, +25.77%).

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