Industry: Next-Gen Sequencing Draft Guidances Have Good Ideas But Need Tweaks

The 37 groups and individuals who submitted comments on FDA’s two draft guidances on next-generation sequencing issued in July expressed appreciation for the thinking behind the guidances, but found bones to pick with some details.

Trade groups and others responding to FDA draft guidance documents on next-generation sequencing (NGS) for diagnosing germline (inheritable) diseases praised the concepts, but questioned some of the specifics of the agency’s plans.

The first guidance document discusses how companies can design, develop and validate their tests that can identify millions of genetic variants relying in part on FDA-recognized standards, while...

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