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華大基因(300676.SZ):BRCA1/2基因突變檢測試劑盒醫療器械註冊申報獲受理
格隆匯 06-05 08:28

格隆匯6月5日丨華大基因(300676.SZ)公佈,全資子公司武漢生物科技的BRCA1/2基因突變檢測試劑盒(聯合探針錨定聚合測序法)於2018年7月通過了國家食品藥品監督管理總局醫療器械技術審評中心的創新醫療器械特別審批。近日武漢生物科技收到國家藥監局下發的《受理通知書》,上述產品的註冊申請獲得受理。

卵巢癌與乳腺癌是女性常見的惡性腫瘤,其中卵巢癌年發病率位居女性生殖系統腫瘤第三位,乳腺癌發病率位居女性惡性腫瘤的首位,嚴重危害女性的身心健康。

BRCA1/2基因是重要的抑癌基因,在DNA損傷修復中發揮關鍵功能。BRCA1/2基因的突變與卵巢癌、乳腺癌等腫瘤的發生發展等密切相關。BRCA1/2基因突變的檢測,對於卵巢癌及乳腺癌患者具有治療藥物選擇和預後評估的指導意義。

公司的BRCA1/2基因突變檢測試劑盒(聯合探針錨定聚合測序法)可用於對臨牀確診為卵巢癌及乳腺癌患者的血液樣本中BRCA1/2基因進行定性檢測及臨牀分級,為致病或疑似致病的胚系BRCA基因突變的卵巢癌及乳腺癌患者使用PARP抑制劑藥物的療效提供較為精準的評估,有助於臨牀制定個體化治療方案。

公司表示,該試劑盒申報醫療器械註冊對公司腫瘤防控業務有積極影響。目前該試劑盒的審批進程僅處於註冊申請受理階段,對公司經營業績不構成直接影響。

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