Shares of Burning Rock Biotech Limited (NASDAQ: BNR) surged over 5% in after-hours trading on October 10th, 2024, after the company announced a significant regulatory approval for its co-developed companion diagnostic test for lung cancer.
Burning Rock and its partner, biopharmaceutical firm Dizal, jointly revealed that the National Medical Products Administration (NMPA) of China has granted marketing approval to their companion diagnostic test for detecting EGFR exon 20 insertion mutations. This test is specifically designed to be used in conjunction with Dizal's EGFR exon 20 insertion mutation-targeted therapy, sunvozertinib, providing a precision treatment solution for non-small cell lung cancer patients with this specific mutation.
The approved companion diagnostic, known as "LungCure CDx," is an NGS-based test that can detect multiple gene mutations, including EGFR, MET, ERBB2, KRAS, BRAF, PIK3CA, ALK, ROS1, and RET in non-small cell lung cancer patients. This approval marks the first co-developed NGS-based companion diagnostic for lung cancer to receive NMPA clearance since the release of China's companion diagnostic guidelines.
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