華大基因(300676.SZ):一項腸癌輔助診斷產品及其配套試劑盒獲得英國MHRA准入資質
格隆匯11月26日丨華大基因(300676.SZ)公佈,公司控股子公司華大數極生物科技(深圳)有限公司(以下簡稱華大數極)的一項腸癌輔助診斷產品及其配套試劑盒於近日獲得了英國MHRA(英文全稱:Medicines & Healthcare products Regulatory Agency;中文譯名:英國藥品和健康產品管理局)准入資質。具體情況如下:

2020年全球癌症(GLOBOCAN)統計報吿顯示,每年有超過190萬的結直腸癌新發病例,佔所有癌症新發病例的10.0%;每年約有93.5萬左右的結直腸癌死亡病例,佔所有癌症死亡病例的9.4%。結直腸癌是全球發病率第三位和死亡率第二位的惡性腫瘤。
此次獲得英國MHRA註冊的產品包括結直腸癌輔助診斷檢測試劑盒及其兩項配套試劑盒。目前,華大數極的結直腸癌輔助診斷產品,從核酸提取、DNA前處理到DNA檢測,三個環節均已取得准入許可,可以為客户提供科學、規範的檢測試劑及服務。
上述產品此前已取得歐盟CE准入資質,此次獲得英國MHRA註冊,進一步提升了公司在腫瘤檢測方面的核心競爭力,對公司腫瘤防控業務將產生積極影響。上述產品實際銷售情況取決於未來市場推廣效果,公司目前尚無法預測其對公司未來業績的影響。
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