Burning Rock Says FDA Grants Breakthrough Device Designation For OverC Multi-Cancer Blood Test
(RTTNews) - Burning Rock (BNR), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced Tuesday 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.
Under the FDA's Breakthrough Devices Program, the Breakthrough Device Designation is granted to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions such as cancer.
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 received CE mark for its OverC MCDBT manufactured in both the US and China facilities. The FDA Breakthrough Device Designation granted for it would pave the way for a clearer registration path through confirmative performance validation and utility establishment.
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