艾德生物(300685.SZ)：获得医疗器械注册证

Core Viewpoint - The company, Adebiotech, has recently received a medical device registration certificate from the National Medical Products Administration of China for its EGFR/ALK/ROS1/MET/KRAS gene mutation detection kit, which is significant for non-small cell lung cancer diagnostics [1] Group 1: Product Approval and Features - The product covers 11 essential and extended genes for non-small cell lung cancer, enabling both DNA and RNA testing [1] - The EGFR, ALK, ROS1, MET, and KRAS genes have been approved for companion diagnostics in China, guiding the clinical application of seven targeted therapies [1] Group 2: Market Reach and Impact - The product has been approved for sale in China, Japan, and Europe, with a total of seven genes approved for companion diagnostics [1] - It supports the clinical application of up to 22 targeted therapies, benefiting numerous non-small cell lung cancer patients globally [1]