【重磅】贝瑞和康“植入前胚胎染色体非整倍体检测试剂盒”通过CFDA创新医疗器械特别审批

近日,经国家食品药品监督管理总局(CFDA)创新医疗器械审查办公室组织有关专家审查,北京贝瑞和康生物技术股份有限公司子公司杭州贝瑞和康基因诊断技术有限公司的“植入前胚胎染色体非整倍体检测试剂盒(可逆末端终止测序法)”通过创新医疗器械特别审批申请审查,将按照《创新医疗器械特别审批程序(试行)》进行审批。


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创新医疗器械特别审批是国家为鼓励医疗器械产业的创新发展,而特意开辟的审批“绿色通道”。申报创新医疗器械的产品作用机理应为国内先行,产品性能或安全性与同类产品比较应有根本性改进,技术上应处于国际先进水平,并且具有显著的临床应用价值。植入前胚胎染色体非整倍体检测试剂盒(可逆末端终止测序法)通过创新医疗器械特别审批,再次彰显了贝瑞和康在产品创新与产品研发上的超强实力。

植入前胚胎染色体非整倍体检测试剂盒(可逆末端终止测序法)

植入前胚胎染色体非整倍体检测试剂盒(可逆末端终止测序法),基于已获得CFDA认证的NextSeq CN500基因测序仪,可对发育至第3天的单个卵裂球或第5天的囊胚滋养层细胞进行检测,一次发现23对染色体的结构和数目异常,为选择正常的胚胎移植提供遗传信息参考。

植入前胚胎染色体非整倍体检测试剂盒(可逆末端终止测序法)所蕴含的SUGA专利核心技术,是贝瑞和康自主研发的全新单细胞扩增技术,能够对单细胞或少量细胞的痕量样本进行高质量、均一化的文库构建,不仅简化临床实验室工作,还可进一步确保稳定可靠的测序结果。这一实验流程只需3步加样,1步纯化,全程3小时完成建库,实现了单管操作,大幅度降低污染,建库成功率高于99%,是目前全球范围内更简单、更快速的胚胎植入前遗传学筛查新方法,非常适合开展大规模的临床应用。SUGA建库所得产物应用广泛,可应用于一代测序、二代测序、芯片等多种平台进行PGS分析,具有超强的临床适应性和显著的临床应用价值。

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贝瑞和康
贝瑞和康成立于2010年5月,致力于应用高通量基因测序技术,为临床医学疾病筛查和诊断提供“无创式”整体解决方案。凭借自主创新的核心技术,贝瑞和康现已拥有覆盖婚前孕前、植入前、产前、新生儿、肿瘤等多生命周期的遗传疾病检测服务与产品,全面布局基因检测产业链的上、中、下游。

贝瑞和康同时与阿里云合作,利用贝瑞和康自主积累的超过400,000份健康人群和10,000份患者的基因组数据信息,打造以海量的中国人群基因组数据为核心的“神州基因组数据云”项目,实现对个人基因组数据的精准解读。

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