Shares of Burning Rock Biotech Limited (NASDAQ: BNR) surged over 15% in pre-market trading on October 11th, 2024, following a significant regulatory approval for its co-developed companion diagnostic test for lung cancer.

Burning Rock and its partner, biopharmaceutical firm Dizal, jointly announced that the National Medical Products Administration (NMPA) of China has granted marketing approval to their Next-Generation Sequencing (NGS)-based companion diagnostic test called "LungCure CDx." This test is designed to detect EGFR exon 20 insertion mutations in non-small cell lung cancer patients and is intended to be used in conjunction with Dizal's EGFR exon 20 insertion mutation-targeted therapy, sunvozertinib.

The approval marks a significant milestone, as LungCure CDx is the first co-developed NGS-based companion diagnostic for lung cancer to receive NMPA clearance since the release of China's companion diagnostic guidelines. This regulatory approval highlights the successful collaboration between Burning Rock and Dizal, and paves the way for a precision treatment solution for lung cancer patients with this specific mutation in China.