First FDA Authorization for Next-Generation Sequencer

Authors:
  • MHMargaret A. Hamburg
    Margaret A. Hamburg
Publisher website
Google Scholar
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 can be sequenced in about 24 hours for what is now less than $5,000 (see graph ). This is a rare example of technology development in which faster, cheaper, and better have coincided: as costs have plummeted and capacity has increased, the accuracy of sequencing has substantially improved. With the FDA's announcement, a platform that took nearly a decade to develop from an initial research project funded by the National Institutes of Health will be brought into use for clinical care. Clinicians can selectively look for an almost unlimited number of genetic changes that may be of medical significance. Access to these data opens the door for the transformation of research, clinical care, and patient engagement.

This publication has 3 references indexed in Scilit: