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FDA outlines ways to assess analytical, clinical performance of NGS ahead of February workshop

from GenomeWeb

The US Food and Drug Administration is considering a standards-based approach for assessing the analytical performance of next-generation sequencing diagnostic tests and using centralized curated databases to evaluate their clinical performance, according to a recent paper published by the agency. The preliminary discussion paper, posted on the FDA's website, outlines possible ways the agency might regulate NGS tests in the future and provides discussion points for a one-day public workshop entitled "Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests" that the FDA will hold at the National Institutes of Health campus in Bethesda, Md., on February 20. more

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