FDA to relax its review of some next-generation genetic tests

WASHINGTON — The Food and Drug Administration will relax its review of some genetic tests that examine millions of different variants at the same time, the agency announced Thursday.

So far, the FDA has not approved any of these broad “next-generation sequencing” tests, but as their cost drops, the agency believes they have more potential to help patients.

“The FDA recognizes the tremendous potential of NGS technology to guide and improve patient outcomes,” said FDA Commissioner Scott Gottlieb in a speech Thursday at a conference hosted by the Community Oncology Alliance.

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