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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The agency also released a third draft guidance describing a voluntary, streamlined submission process to determine whether an investigational in vitro diagnostic being codeveloped alongside a cancer drug in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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Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.