Burning Rock Biotech’s cancer detection test designated Breakthrough Device

Burning Rock’s OverC Multi-Cancer Detection Blood Test has been granted Breakthrough Device Designation by the 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. OverC MCDBT demonstrated a 69.1% of sensitivity and 98.9% of specificity in the case-control study, THUNDER, and will be further validated in prospective interventional studies among asymptomatic population. Compared with conventional cancer screening methods, liquid biopsy has the potential to increase detection efficiency and enable early diagnosis and treatment, thus improving patients’ survival and quality of life while reducing social burden of the disease. In May 2022, Burning Rock received CE mark for its OverC MCDBT manufactured in both the US and China facilities. The FDA Breakthrough Device Designation granted for OverC MCDBT would pave the way for a clearer registration path through confirmative performance validation and utility establishment.