艾德生物(300685.SZ):“人EGFR/ALK/ROS1/MET基因突變檢測試劑盒(多重熒光PCR法)”獲醫療器械註冊證
格隆匯9月6日丨艾德生物(300685.SZ)公佈,公司於近日獲得由國家藥品監督管理局頒發的《中華人民共和國醫療器械註冊證》。相關產品為人EGFR/ALK/ROS1/MET基因突變檢測試劑盒(多重熒光PCR法),用於體外定性檢測非小細胞肺癌(NSCLC)患者福爾馬林固定石蠟包埋(FFPE)樣本DNA/RNA中人類EGFR、ALK、ROS1和MET基因14號外顯子跳躍突變,具體突變位點信息詳細見説明書。其中EGFR基因19號外顯子缺失突變和L858R突變可用於鹽酸厄洛替尼片和甲磺酸奧希替尼片的伴隨診斷;EGFR基因T790M突變可用於甲磺酸奧希替尼片的伴隨診斷;ALK基因融合和ROS1基因融合可用於克唑替尼膠囊的伴隨診斷;MET基因外顯子14跳躍突變可用於谷美替尼片和鹽酸特泊替尼片的伴隨診斷。
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