NEW YORK – Burning Rock Biotech said on Tuesday that the National Medical Products Administration of China has approved its nine-gene sequencing assay, LungCure CDx, as a Class III medical device.
LungCure CDx represents the company's second multi-gene reagent kit approval in China, joining a prior six-gene assay approved by NMPA in 2018.
The tissue-based sequencing test detects genetic variants in exons and some intronic regions of EGFR, ALK, ROS1, KRAS, MET, ERBB2, BRAF, PIK3CA and RET, which are known to sensitize individuals with lung cancer to genomically targeted therapies. Three of the genes — EGFR, ALK, and ROS1 — are specifically approved under the NMPA standards for companion diagnostics.
Burning Rock said LungCure CDx is the first NGS-based reagent kit approved in China that includes the detection of MET amplification and MET exon 14 skipping. The firm added that the assay is part of several CDx development collaborations with "well-known pharmaceutical companies."