華大基因(300676.SZ):華大數極腸癌輔助診斷產品獲歐盟CE准入資質
格隆匯5月19日丨華大基因(300676.SZ)宣佈,公司控股子公司華大數極生物科技(深圳)有限公司的一項腸癌輔助診斷產品於近日獲得了歐盟CE准入資質。該試劑盒適用於體外定性檢測人糞便樣本中SDC2、ADHFE1、PPP2R5C基因的甲基化情況。
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。
此次獲得歐盟CE准入資質的結直腸癌輔助診斷產品是針對人糞便樣本人源基因組中與結直腸癌發生發展相關的甲基化標誌物進行檢測,適用於臨牀結直腸癌的輔助診斷。
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