TEST:

LungCure™ CDx

"Burning Rock Biotech Limited...and Dizal...jointly announced that the companion diagnostic (CDx) for EGFR exon 20 insertion mutation (exon20ins) for sunvozertinib, developed through their collaboration, has been approved by the National Medical Products Administration (NMPA) of China. This marks the first co-developed NGS-based CDx for lung cancer approved by NMPA since the release of the CDx guideline in China. The approval of this CDx test is the result of the simultaneous development of Burning Rock's independently developed LungCure CDx (a kit for the combined detection of 9 human gene mutations) and Dizal's innovative EGFR exon20ins targeted therapy - sunvozertinib, providing an innovative precision treatment solution for non-small cell lung cancer patients with EGFR exon20ins."

"Burning Rock Biotech Limited...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."