Workshop Attendees Help Advance FDA Thinking on Analytical, Clinical Validity Standards for NGS | GenomeWeb

SILVER SPRING, Maryland – At a two-day workshop held here last week to discuss regulatory standards for next-generation sequencing tests, industry stakeholders, academicians, and researchers considered whether a prescriptive framework or more general guidelines are needed to establish the analytical validity of such tests, and how curated databases might be used to gather information on the clinical validity of the assessed markers.

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