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NEW YORK (GenomeWeb) – The US Food and Drug Administration today finalized two guidances on the design, development, and validation of next-generation sequencing tests.

The agency also released a third draft guidance describing a voluntary, streamlined submission process to determine whether an investigational in vitro diagnostic being codeveloped alongside a cancer drug in a trial confers significant risk and may require an investigational device exemption submission, or confers non-significant risk and is exempt.

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