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華大基因(300676.SZ):子公司兩項HPV檢測產品完成歐盟CE認證
格隆匯 11-12 12:02

格隆匯11月12日丨華大基因(300676.SZ)宣佈,公司全資子公司BGI Europe A/S(以下簡稱歐洲醫學”)的兩項HPV檢測相關產品於近日完成了歐盟CE認證。

其中,Nucleic AcidExtraction Kit(中文譯名:核酸提取試劑)預期用於核酸的提取、富集、純化,其處理後的產物用於臨牀體外檢測使用。

Human Papillomavirus (HPV) Typing Kit(Combinatorial Probe-Anchor Synthesis Sequencing Method)(中文譯名:人乳頭瘤病毒(HPV)分型檢測試劑盒(聯合探針錨定聚合測序法))採用新一代高通量測序檢測技術(聯合探針錨定聚合測序法)針對女性宮頸脱落上皮細胞中的17種人乳頭瘤病毒(HPV16、18、31、33、35、39、45、51、52、53、56、58、59、66、68、73、82)的核酸進行定性和分型檢測,用於人乳頭瘤病毒感染的輔助診斷。

2018年全球癌症(GLOBOCAN)統計報告顯示,每年約有50萬左右的宮頸癌新發病例,佔所有癌症新發病例的3.2%,是女性發病率和死亡率第四位的惡性腫瘤。持續的高危型人乳頭瘤病毒(HPV)感染是宮頸癌及癌前病變的首要因素。

此次獲得歐盟CE資質的人乳頭瘤病毒(HPV)分型檢測試劑盒(聯合探針錨定聚合測序法)和其適用的核酸提取試劑,用於17種高危及中等風險型別HPV(HPV16、18、31、33、35、39、45、51、52、53、56、58、59、66、68、73、82型)的精準分型檢測,有助於HPV感染者的及早診治以及宮頸癌的防控。

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