First FDA Authorization for Next-Generation Sequencer

被引:130
作者
Collins, Francis S. [1 ]
Hamburg, Margaret A. [2 ]
机构
[1] NIH, Off Director, Bethesda, MD 20892 USA
[2] US Dept HHS, US FDA, Off Commissioner, Silver Spring, MD USA
关键词
D O I
10.1056/NEJMp1314561
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
The FDA has granted marketing authorization for a high-throughput genomic sequencer, Illumina's MiSeqDx, which will allow the development of innumerable new genome-based tests. Access to genomic data may transform research, clinical care, and patient engagement. This year marks 60 years since James Watson and Francis Crick described the structure of DNA and 10 years since the complete sequencing of the human genome. Fittingly, today the Food and Drug Administration (FDA) has granted marketing authorization for the first high-throughput (next-generation) genomic sequencer, Illumina's MiSeqDx, which will allow the development and use of innumerable new genome-based tests. When a global team of researchers sequenced that first human genome, it took more than a decade and cost hundreds of millions of dollars. Today, because of federal and private investment, sequencing technologies have advanced dramatically, and a human genome ...
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收藏
页码:2369 / 2371
页数:3
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