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US FDA's Next-Gen Sequencing Guidances: One Stop On A Pathway

Two recent next-generation sequencing draft guidances have been positively received so far by industry and clinical research groups. But for FDA's ideas to play out, more databases will need to be populated and more standards developed, agency officials say. There are also more guidances to come on different types of NGS tests. Read our coverage below, and also listen to our podcast interview with FDA's Elizabeth Mansfield.

DNA

US FDA hopes its two recent draft-guidance documents for companies developing next-generation sequencing diagnostics will spur development of new NGS databases and standards – the very tools that the guidance documents rely on to outline a new regulatory paradigm for these assay types.

The agency issued a draft guideline earlier this month addressing how to employ standards to support regulatory approval of germline NGS tests, and a separate document addressing how...

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