睿昂基因(688217.SH):公司預計人EGFR基因T790M突變檢測試劑盒將於2023年底前獲得三類醫療器械證書
格隆匯9月6日丨睿昂基因(688217.SH)接受特定對象調研時表示,公司和藥企合作共同申請人EGFR基因T790M突變檢測試劑盒的第三類醫療器械註冊證,在具體的臨牀實驗中,公司選擇了藥企的機器作為主機型,同時使用了公司子公司技特生物的機器做了對比實驗,兩者在檢測性能上無較大的差別。在T790M產品的"發補"過程中,藥企撤銷了審核,導致公司在評估過程中檢測的病例數不充足。經公司與藥監局溝通,藥監局同意公司將藥企做過的樣本重新再做一遍。但公司在對一些樣本重新檢測時,一些醫院要求公司重新走臨牀試驗的流程,拖累了報證的進度,公司預計人EGFR基因T790M突變檢測試劑盒將於2023年底前獲得三類醫療器械證書。
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