FDA clears the way for more consumer genetic health tests to hit the market

The floodgates for direct-to-consumer genetic tests are swinging wide open.

The Food and Drug Administration plans on loosening many of the regulations surrounding genetic health risk tests, or GHRs, according to a statement Monday from Commissioner Scott Gottlieb. It’s a change of course for the agency, which in 2013 put a freeze on direct-to-consumer marketing of genetic tests for health conditions.

Since then, the FDA has generally been approving tests one by one before they hit the market.

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