TEST:

OverC™

"Burning Rock Biotech Limited...is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA."

"Burning Rock...announced that its OverC™ Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally...OverC™ MCDBT is intended for early detection of multiple cancer types (esophageal, liver, lung, ovarian, and pancreatic cancers) in adults of either sex, aged 50-75 years old, at average risk for cancer."

"Burning Rock Biotech Limited...announced the launch of the PREVENT (a Prospective multi-canceR Early-detection and interVENTional) study, China’s first prospective interventional study to evaluate the performance of Burning Rock's early cancer detection test, OverC™, in the asymptomatic population. The study is expected to enroll 12,500 asymptomatic individuals, to evaluate the performance of the OverC™ test in detecting 6 cancers (lung, liver, colorectal, esophageal, pancreatic and ovarian cancers)."

"Burning Rock Biotech Limited...announced that it has received CE marking for its OverC™ Multi-Cancer Detection Blood Test manufactured in both the US and China facilities...The approval of CE mark for the OverC™ test is of much significance for the commercialization and compliance process of Burning Rock's multi-cancer early detection technology and marks a breakthrough in the company's global business strategy."