Burning Rock receives Breakthrough Device Designation from China’s NMPA

Burning Rock Biotech announced that followed an earlier Breakthrough Device Designation granted by the U.S. Food and Drug Administration for its OverC Multi-Cancer Detection Blood Test in January 2023, its OverC MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration, which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA. OverC MCDBT is intended for early detection of multiple cancer types 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 achieved a superior tissue traceability capabilities-the prediction accuracy of TPO1 and TPO2 was 83.2% and 91.7%, respectively. The technology and validation data have been released on Annals of Oncology in March 2023, showing an impressive performance of ELSA-seq using cfDNA in cancer detection and origin prediction.