華大基因(300676.SZ)：新型冠狀病毒核酸檢測產品獲得加拿大衞生部認證
格隆匯5月6日丨華大基因(300676.SZ)公佈，公司控股子公司BGI Americas Corporation(“美洲華大”)於近日收到加拿大衞生部簽發的3類醫療器械產品註冊證，美洲華大的新型冠狀病毒核酸檢測產品獲得了加拿大衞生部認證。
產品名稱：REAL-TIME FLUORESCENT RT-PCR KIT FOR DETECTING SARS-COV-2(中文譯名：新型冠狀病毒SARS-COV-2核酸檢測試劑盒(熒光PCR法))
預期用途：本試劑盒適用於定性檢測新型冠狀病毒感染的肺炎疑似患者，通過檢測從受檢者樣本中提取的核酸以確定受檢者是否有新型冠狀病毒感染。
有效期限：僅在加拿大衞生部關於新型冠狀病毒肺炎疫情COVID-19醫療器械進口及銷售的臨時命令生效期間有效。
新型冠狀病毒的核酸檢測是新型冠狀病毒肺炎感染確診的重要手段之一，新型冠狀病毒核酸檢測試劑盒是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。公司研發的新型冠狀病毒核酸檢測試劑盒可實現病毒的快速檢測，協助各國當局和醫療機構等採取及時有效的防控措施，較好地滿足各國疫情防控的市場需求。
截至公告披露日，共計十餘家國內外企業的新型冠狀病毒檢測產品獲得了加拿大衞生部認證，其中公司是在加拿大市場率先獲批新型冠狀病毒檢測試劑盒的中國企業。
截至目前，公司該檢測產品獲得的批准情況如下：在國內市場，已取得了中國國家藥品監督管理局頒發的醫療器械注冊證；在歐洲市場，完成了歐盟CE 認證，並獲得了歐盟自由銷售證書；在美國市場，已獲得了美國食品藥品監督管理局(“FDA”)簽發的緊急使用授權(EUA)；在日本市場，已通過了日本PMDA 認證；在澳大利亞市場，已獲得了澳大利亞TGA註冊；在新加坡市場，已獲得新加坡衞生科學局的臨時授權。
此次公司產品獲得加拿大衞生部認證，標誌着美洲華大具備了在加拿大市場進口或銷售上述產品的資格，有利於進一步提升公司產品的國際競爭力，在全球範圍內助力新型冠狀病毒感染的肺炎疫情防控工作。上述產品實際銷售情況取決於新型冠狀病毒感染的肺炎疫情防控涉及的檢測需求，公司目前尚無法預測其對公司未來業績的影響，敬請投資者注意投資風險。
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