華大基因(300676.SZ):子公司兩項新冠檢測產品獲得CE准入資質
格隆匯 2 月 10日丨華大基因(300676.SZ)公佈,公司控股子公司深圳華大因源醫藥科技有限公司(以下簡稱華大因源)研製的兩項新型冠狀(以下簡稱新冠)病毒檢測產品於近日獲得歐盟CE准入資質。具體情況如下:


2020年12月,英國向世界衞生組織通報出現新的B.1.1.7新冠病毒株,相關科學研究表明,該變異病毒傳播能力比原始毒株更高。快速對B.1.1.7新冠變異病毒作出鑑定已成為目前各國疫情防控工作的重點之一。公司本次獲得CE准入資質的第一項產品新冠病毒B.1.1.7突變株快速檢測試劑盒(ARMS-PCR法)採用擴增阻滯突變PCR方法,可實現野生型病毒株(501N和681P)和突變型病毒株(501Y和681H)的鑑別診斷,從而有利於新冠病毒變異株的監測。
公司此次獲得CE准入資質的第二項產品新冠病毒快速核酸檢測試劑盒(PCR熒光探針法)採用體外PCR擴增和熒光探針相結合的方法,針對新冠病毒2019-nCoV的高度保守區域以及內參基因設計熒光檢測的特異性引物探針。該試劑盒通過採用快速生化反應模式,縮短了檢測時間,從而有利於提高新冠病毒檢測的效率。
根據歐盟《體外診斷醫療器械指令》規定,華大因源研製的新冠病毒B.1.1.7突變株(N501Y和P681H)快速檢測試劑盒(擴增阻滯突變PCR法)和新冠病毒快速核酸檢測試劑盒(PCR熒光探針法)產品已經完成了CE申報,並得到了主管機構的確認,這兩項檢測產品已具備歐盟市場的准入條件。
上述檢測產品獲得CE准入資質,有利於進一步豐富公司新冠病毒檢測產品矩陣,增強公司新冠病毒檢測產品的綜合競爭力,滿足多種應用場景的臨牀需求,全面助力新冠疫情防控工作。上述產品實際銷售情況取決於新冠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。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.