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 to leverage
Elizabeth Mansfield, who heads personalized medicine activities within FDA's device center, acknowledges, however, that companies have slim