贝康医疗-B(02170):PGT-A试剂盒获国家药监局颁发医疗器械注册证

智通财经
Mar 16

智通财经APP讯,贝康医疗-B(02170)公布,公司基于国产高通量基因测序平台的 PGT-A试剂盒,胚胎植入前染色体非整倍体检测试剂盒(联合探针锚定聚合测序法),于2026年3月13日成功获批国家三类医疗器械注册证(注册证号:国械注准20263400529),成为全国首个基于纯国产自主平台测序仪的PGT-A试剂盒。此试剂盒适用于35岁及以上试管婴儿患者、染色体异常夫妇、三次以上移植失败或自然流产人群及生育过异常患儿的家庭,透过检测胚胎部分细胞DNA分析染色体非整倍体异常,辅助临床植入决策,标志着我国辅助生殖遗传检测领域实现“设备 — 试剂 — 分析软体”全链条国产化突破,为中国健康事业注入强劲的“中国芯”。

PGT-A试剂盒透过筛检胚胎染色体非整倍体异常,能有效降低流产风险和出生缺陷发生率,是第三代试管婴儿技术的关键支撑。公司此次核准的试剂盒经过多年技术攻关,在检测准确性、平台适配性和临床实用性上完成多中心系统性验证,填补了纯国产自主平台测序仪在PGT-A领域的应用空白,为临床提供了更具自主可控性的检测选择。

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