貝瑞基因(000710.SZ):胎兒染色體拷貝數變異檢測試劑盒通過醫療器械註冊檢驗
格隆匯12月21日丨貝瑞基因(000710.SZ)公佈,公司全資子公司杭州貝瑞和康基因診斷技術有限公司於近日收到中國食品藥品檢定研究院下發的醫療器械註冊檢驗報吿:胎兒染色體拷貝數變異檢測試劑盒(可逆末端終止測序法)技術要求檢驗結果符合規定。
該試劑盒系公司經典的貝比安無創DNA產前檢測產品的升級版,檢測範圍從產前胎兒染色體非整倍體擴展至胎兒染色體微缺失綜合徵,可進一步有效降低新生兒羣體出生缺陷率。
目前該試劑盒僅通過註冊檢驗,公司將繼續完成醫療器械註冊申報流程。未來,該產品若獲批上市,將進一步豐富公司生育健康領域產品管線,加強公司在基因測序領域的市場競爭力,預計將對公司未來經營產生積極影響。
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