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, 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.
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.
The arrival of next-generation sequencing at this regulatory landmark is only the beginning. We need to work together to ensure that research progresses, that regulatory policies are developed, that patients’ rights and needs are addressed, and that clinical use of genomic information is based on rigorous evidence.
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Read the full, original story here: First FDA Authorization for Next-Generation Sequencer
