FDA Releases Proposed Guidances For Next Generation Sequences

Last week the Obama Administration released one of its periodic fact sheets announcing recent actions on the Precision Medicine Initiative (PMI).  The PMI is trying to build tools and gather data to make it easier to target therapies and other medical treatments for specific individuals.

Part of this latest fact sheet is the announcement that the Food and Drug Administration (FDA) is releasing draft guidance on oversight for what’s called next generation sequencing (NGS).  This category of tests measures a much higher number of genetic variants than current sequencing.  The agency believes that these draft guidances – one on standards for analytical validity of NGS tests and another on using evidence from public genome databases to demonstrate the clinical validity of NGS tests – can be sufficiently flexible for a family of tests that is emerging and notably distinct from existing sequencing and related tests.  This is a situation where the agency likely believes that establishing some boundaries for a new testing field can support the development of such tests.

If you’re interested in providing comment on either draft guidance (or both), you will need to submit them by October 6.

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