华大基因(300676.SZ)：子公司两项新冠检测产品获得CE准入资质
格隆汇 2 月 10日丨华大基因(300676.SZ)公布，公司控股子公司深圳华大因源医药科技有限公司(以下简称华大因源)研制的两项新型冠状(以下简称新冠)病毒检测产品于近日获得欧盟CE准入资质。具体情况如下：
2020年12月，英国向世界卫生组织通报出现新的B.1.1.7新冠病毒株，相关科学研究表明，该变异病毒传播能力比原始毒株更高。快速对B.1.1.7新冠变异病毒作出鉴定已成为目前各国疫情防控工作的重点之一。公司本次获得CE准入资质的第一项产品新冠病毒B.1.1.7突变株快速检测试剂盒(ARMS-PCR法)采用扩增阻滞突变PCR方法，可实现野生型病毒株(501N和681P)和突变型病毒株(501Y和681H)的鉴别诊断，从而有利于新冠病毒变异株的监测。
公司此次获得CE准入资质的第二项产品新冠病毒快速核酸检测试剂盒(PCR荧光探针法)采用体外PCR扩增和荧光探针相结合的方法，针对新冠病毒2019-nCoV的高度保守区域以及内参基因设计荧光检测的特异性引物探针。该试剂盒通过采用快速生化反应模式，缩短了检测时间，从而有利于提高新冠病毒检测的效率。
根据欧盟《体外诊断医疗器械指令》规定，华大因源研制的新冠病毒B.1.1.7突变株(N501Y和P681H)快速检测试剂盒（扩增阻滞突变PCR法）和新冠病毒快速核酸检测试剂盒(PCR荧光探针法)产品已经完成了CE申报，并得到了主管机构的确认，这两项检测产品已具备欧盟市场的准入条件。
上述检测产品获得CE准入资质，有利于进一步丰富公司新冠病毒检测产品矩阵，增强公司新冠病毒检测产品的综合竞争力，满足多种应用场景的临床需求，全面助力新冠疫情防控工作。上述产品实际销售情况取决于新冠疫情防控涉及的检测需求，公司目前尚无法预测其对公司未来业绩的影响。
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