艾德生物(300685.SZ):肺癌多基因聯合檢測產品PCR-11基因進入日本醫保
格隆匯1月7日丨艾德生物(300685.SZ)公佈,公司基於PCR技術平台自主研發的肺癌多基因聯合檢測產品“AmoyDx® Pan lung cancer PCRpanel”(即PCR-11基因)於近日被納入日本醫保。該產品用於檢測多個肺癌核心驅動基因。據悉,PCR-11基因已於2021年6月獲得日本醫藥品醫療器械綜合機構批准上市。
該產品囊括了EGFR、ALK、ROS1、BRAF、RET、MET、HER2、KRAS、NTRK1、NTRK2、NTRK3共11個肺癌核心驅動基因,涵蓋了《非小細胞肺癌分子病理檢測臨牀實踐指南(2021版)》中推薦肺癌一線檢測必檢基因及罕見突變基因,是禮來、安進、默克等藥企腫瘤藥物臨牀試驗的伴隨診斷。其具有靈敏度高、特異性好、操作簡便、出報吿時間短、適用樣本類型廣等特點,有助於臨牀快速且全面地篩查出靶向治療受益人羣。
公司表示,該產品進入日本醫保,有利於進一步增強公司海外市場競爭力,對公司未來的發展將產生積極影響。
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