智通财经APP讯，贝康医疗-B(02170)发布公告，公司自主研发的PGT-A试剂盒医疗器械注册证(注册证号：国械注准20203400181)于2024年10月成功获得国家药品监督管理局批准续期，将其注册证书续期五年至2030年2月20日(可予进一步续期)。
2020年2月，公司的PGT-A试剂盒获得国内首个“创新医疗器械特别审批”的三类医疗器械注册证。该试剂盒基于高通量测序技术，能够精准检测囊胚滋养层细胞的DNA，分析胚胎是否存在染色体非整倍体异常，为医生提供判断胚胎适合植入的依据，填补了国内PGT检测试剂盒领域的临床空白。
PGT-A试剂盒是国内首个经逾10万例临床样本验证临床有效性的PGT检测试剂盒。自开展PGT-A试剂盒的临床试验以来，公司在临床试验机构中累计收集了超过10万个例胚胎的临床资料，该资料与PGT-A试剂盒的检测结果一致性达 100%，充分证明了其能有效满足目前的临床检测需求。国家药监局对PGT-A试剂盒医疗器械注册证的续期批准也意味着其临床有效性得到了监管部门的认可。
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