Genetron's Technology Receives U.S. FDA Breakthrough Device Designation

Upon approval, Genetron's technology will be covered by the Federal Medical Insurance and U.S. Medicaid Services.
CapitalWatch StaffNov 12,2020,18:38

HCCscreen, a blood-based next-generation sequencing (NGS) test, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). The test is independently developed by Genetron Holding Ltd. (Nasdaq: GTH).

This is the first time that a Chinese precision oncology platform receives certification for an early screening liquid biopsy product.

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.

“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,” said Sizhen Wang, Genetron Health’s co-founder and CEO.

HCCscreen is powered by Genetron Health’s innovative and proprietary Mutation Capsule technology, which enables detection of multiple methylation alterations in parallel with mutations in cell-free DNA from peripheral blood specimens.

As of September, 2,000 patients have already completed the study, and preliminary data from 297 patients at one center has demonstrated over 92% sensitivity and 93% specificity.

Furthermore, stratifying by tumor sizes, of the 12 patients identified with HCC in the preliminary dataset, 10 patients had tumor sizes of less than 5 cm, indicating HCCscreen’s detection ability in early-stage HCCs.

The company said that after obtaining the U.S. FDA Breakthrough Medical Device certification all future HCCscreen-related applications will receive priority review.

Upon approval, the technology will be covered by the Federal Medical Insurance and U.S. Medicaid Services.

Based in Beijing, Genetron provides precision oncology solutions including early screening, diagnosis, treatment recommendations, and monitoring.

On June 19, Genetron lifted off in a $256 million initial public offering in New York, selling 16 million American depositary shares at $16 apiece.

This article is a translation from

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Topics:MedTech, genetron