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U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

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N Engl J Med 2013 Dec 19;369(25):2369-71

First FDA Authorization for Next-Generation Sequencer.

Collins FS, Hamburg MA


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 . . .

Category: Journal Article, Editorial
PubMed ID: #24251383 DOI: 10.1056/NEJMp1314561
Includes FDA Authors from Scientific Area(s): Women's Health
Entry Created: 2013-11-22 Entry Last Modified: 2014-01-19