First FDA Authorization for Next-Generation Sequencer.

Source

From the Office of the Director, National Institutes of Health, Bethesda, MD (F.S.C.); and the Office of the Commissioner, Food and Drug Administration, Department of Health and Human Services, Silver Spring, MD (M.A.H.).

Abstract

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 . . .