The FDA Slacks Regulations On Genetic Health Risk Tests

The U.S. Department of Health and Human Services Food and Drug Administration

Some regulatory hurdles for makers of direct-to-consumer genetic health risk test have been lifted, according to a notice published by the US Food and Drug Administration.

The new regulations would enable genetic health tests on the market, without having a prior review. Instead of the normal routine, companies wanting to sell a test would come to the FDA for a one-time review.


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The decision didn’t come unexpectedly, as the FDA hinted that the agency could soon be loosening their regulations associated with genetic health risk tests in November, last year. 

However, there are exceptions to the types of tests that could be commercialised under the classification: prenatal testing, cancer predisposition testing, and genetic diagnosis of deterministic autosomal dominant variants.