迪瑞醫療(300396.SZ)：取得5項醫療器械註冊證 涉及人類免疫缺陷病毒抗原及抗體聯合檢測試劑盒等
格隆匯2月17日丨迪瑞醫療(300396.SZ)公佈，公司於近日取得由國家藥品監督管理局頒發的5項《醫療器械註冊證》，分別為人類免疫缺陷病毒抗原及抗體聯合檢測試劑盒(化學發光免疫分析法)、總前列腺特異性抗原測定試劑盒(化學發光免疫分析法)、糖類抗原19-9測定試劑盒(化學發光免疫分析法)、遊離前列腺特異性抗原測定試劑盒(化學發光免疫分析法)、癌胚抗原測定試劑盒(化學發光免疫分析法)。
化學發光免疫分析作為體外診斷行業最重要的細分項目之一，其臨牀應用涵蓋多個病種，包括腫瘤、甲功、激素、傳染病、心臟標誌物等。化學發光免疫分析技術目前在歐美等發達國家已經成為臨牀試驗室廣泛使用的常規檢測技術。對於國內市場來説，目前化學發光檢測產品大部分為國外大廠商生產的產品，我國化學發光檢測產業還處於發展期。不過隨着國內廠商技術的不斷進步，差距在不斷縮小，近些年國內湧現出了一批較具代表性的廠家。
公司新推出的人類免疫缺陷病毒抗原及抗體聯合檢測試劑盒，為第四代人類免疫缺陷病毒(HIV)檢測試劑盒，能夠有效縮短人類免疫缺陷病毒(HIV)檢測窗口期，提高檢測率。此項產品的獲准上市，標誌着公司擁有了完善的術前八項免疫檢查套餐。
目前，公司化學發光免疫分析檢測試劑產品已覆蓋乳腺癌、卵巢癌、胃癌、胰腺癌、肝癌、前列腺癌、肺癌等多種腫瘤診斷與治療的應用中。
上述《醫療器械註冊證》的取得，豐富了公司產品種類，配合CSM-8000模塊化生化免疫分析系統、CM-320全自動化學發光免疫分析儀、CM-180全自動化學發光免疫分析儀等公司相關產品使用，將進一步增強公司綜合競爭力，有利於進一步提高公司的市場拓展能力，對公司未來的經營將產生積極影響。上述產品實際銷售情況取決於未來市場推廣效果，公司目前尚無法預測其對公司未來業績的影響，敬請投資者注意投資風險。公司未來會積極推動相關產品在國內市場的銷售，為廣大股東創造更大的價值。
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