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FDA Maps Out Novel Path For NGS Market Access

FDA Commissioner Robert Califf says the agency has worked with NIH and other experts as part of President Obama's Precision Medicine Initiative to map out a new regulatory framework for next-generation sequencing. He said two new draft guidances are meant to help get such tests to market sooner without requiring developers to validate individual genetic variations.

Two guidances on next-generation sequencing map out approaches for NGS developers to bring their product to market by relying on established standards and databases rather than new clinical studies to validate individual markers.

Speaking to reporters July 6 during a conference call hosted by the White House on president Obama's Precision Medicine Initiative, FDA Commissioner Robert Califf said development and growth of NGS...

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