Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its AiHuiJie, a companion diagnostic (CDx) reagent designed for lung cancer. This PCR-based product is capable of detecting 11 key driver genes associated with lung cancer in a single test, including EGFR, HER2, KRAS, BRAF, MET, ALK, ROS1, RET, and NTRK1-3. Known for its accuracy, high success rate, stability, and rapid reporting, AiHuiJie requires a minimal sample size, making it a critical tool for the first-line diagnosis of non-small cell lung cancer (NSCLC) patients. The product has previously been granted marketing approval in Japan and the European Union. – Flcube.com
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