邁克生物(300463.SZ):新冠檢測產品獲得美國FDA緊急使用授權
格隆匯4月16日丨邁克生物(300463.SZ)公佈,公司的新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)於美國時間2020年4月15日獲得美國食品藥品監督管理局(英文全稱“Food And Drug Administration”,下稱“FDA”)簽發的緊急使用授權(英文全稱“Emergency Use Authorization”,下稱“EUA”)。
公司此次獲得FDA簽發的EUA授權的新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)為三重靶標設計,較一個靶標和兩個靶標設計的試劑盒,能更大程度避免新冠病毒的漏檢,臨牀試驗顯示試劑盒擁有良好的試劑性能,靈敏度和特異性高,檢驗耗時相對較短,可實現2個小時內完成96個測試。此前,公司該產品已獲得中國國家藥品監督管理局頒發的醫療器械註冊證。同時,該產品已取得歐盟CE認證。
新型冠狀病毒感染的肺炎疫情在全球爆發,對人們生命健康造成巨大威脅。新型冠狀病毒核酸檢測試劑基於直接對病毒抗原進行檢測而成為目前各國進行體外定性檢測新型冠狀病毒感染的肺炎疑似病例和其他需要進行新型冠狀病毒感染鑑別診斷者的主要方法。公司新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)可實現病毒的快速檢測,可為各國開展及時有效的新冠疫情防控措施提供檢測產品支持,滿足各國疫情防控的市場需求。
公司指出,公司新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)是根據美國《新型冠狀病毒肺炎在公共危機下的診斷檢測政策指南》獲得的在公共危機下新型冠狀病毒檢測產品正式進入美國臨牀市場銷售的資質,是產品的臨時使用,如果在緊急情況終止後,則需另行向美國FDA提交產品註冊申請。
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