基因测序技术在临床检验领域的应用及国内外监管现状比较研究  

Application of Gene Sequencing Technology in the Field of Clinical Testing and Comparative Study on Current Situation of Domestic and International Supervision

作　　者：刘可君 郭世富[1] 崔乐 黄颖[1] Liu Kejun;Guo Shifu;Cui Le;Huang Ying(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2018年第11期1520-1530,共11页Chinese Pharmaceutical Affairs

摘　　要：基因测序技术是现代分子生物学研究中最常用的技术,从1977年第一代测序技术的出现,经过四十多年的发展,基因测序技术取得了重大进展,尤其以高通量为特点的第二代测序技术正在逐步应用于临床检测中。本文介绍了基因测序技术的发展及国内外第二代测序技术在临床应用中的监管制度和监管建议。Gene sequencing technology is the most commonly used technique in modern molecular biology research. Since the emergence of the first generation sequencing technology in 1977, it has made significant progress after development of forty years. Now the second generation sequencing technology characterized by high throughput is applied to clinical testing. This paper introduces the development of gene sequencing technology, its regulatory regime and regulatory recommendations for clinical applications of the second generation sequencing technology at home and abroad.

关 键 词：基因测序技术 临床应用 标准化 监管 

分 类 号：Q75[生物学—分子生物学]