Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that the National Medical Products Administration (NMPA) approved Burning Rock’s Human Nine-Gene Mutation Joint Detection Kit (reversible termination sequencing) (LungCure™ CDx) as a class III medical device. This approval demonstrates Burning Rock’s industry-leading capability of working with the NMPA on bringing an innovative next generation sequencing (NGS)-based diagnostic product to the China market.
LungCure™ CDx is the Company’s second NMPA-approved NGS-based reagent kit for multiple gene mutation, following our industry-first kit approval in 2018. LungCure™ CDx can be used in in vitro detections of genetic variations of EGFR, ALK, ROS1, KRAS, MET, ERBB2, BRAF, PIK3CA and RET genes associated with non-small cell lung cancer (NSCLC) patients, three of which (EGFR, ALK and ROS1) are approved under the NMPA standards for companion diagnostics (CDx), and provide comprehensive guidance on NSCLC targeted therapy.
LungCure™ CDx has significantly improved the detection capability of rare variant types. It is the first NGS-based reagent kit approved in China which has the ability to detect MET amplification and MET exon 14 skipping. At the same time, LungCure™ CDx has reached a number of CDx development collaborations with well-known pharmaceutical companies.
LungCure™ CDx targets and captures exons and some intron regions of the above nine genes that are highly related to the personalized treatment of NSCLC in NCCN/CSCO Guidelines, covering point mutation, indel, fusion (rearrangement) and amplification. LungCure™ CDx significantly improves the detection performance and detection range of rare genetic variations, such as MET amplification, MET exon 14 skipping, ALK rearrangement, ROS1 rearrangement, RET rearrangement, etc., benefiting more patients clinically.
Source: Company Press Release
