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華大基因(300676.SZ):地中海貧血基因檢測試劑盒國內獲批
格隆匯 04-15 16:14

格隆匯4月15日丨華大基因(300676.SZ)公佈,公司全資子公司華大生物科技(武漢)有限公司的α和β地中海貧血基因檢測試劑盒(聯合探針錨定聚合測序法)(簡稱“地中海貧血基因檢測試劑盒”)於近日取得了國家藥品監督管理局頒發的醫療器械註冊證。

地中海貧血是一種因珠蛋白合成障礙導致的遺傳性溶血性疾病,是全球分佈廣泛、累及人羣較多且危害嚴重的一種單基因遺傳病。

地中海貧血難治但可防,通過婚前、孕前和產前階段對育齡人羣進行地中海貧血篩查、診斷和干預,可以有效降低中、重型地中海貧血患兒出生。公司是高通量測序技術檢測地中海貧血的引領者,在國產自主知識產權的高通量測序平台上開發的地中海貧血基因檢測新技術具有準確率高、檢測全面、高通量和低成本等優勢,為全球的地中海貧血防控提供了一種新的技術方案,有助於更好地防控血紅蛋白病。

公司該次獲批的地中海貧血基因檢測試劑盒是國內率先獲批的基於高通量測序技術的地中海貧血的基因檢測試劑盒,可以一次性同時檢測α和β地中海貧血的缺失型和非缺失型變異,填補了國內β地中海貧血基因缺失型檢測的空白。該試劑盒具有檢測靈敏度和特異性高、多測序平台通量配置靈活等特點,可滿足臨牀用户的多樣化和個性化需求。

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