FDA approves first home genetic health risk test


The Food and Drug Administration authorized 23andMe’s Personal Genome Service Genetic Health Risk (GHR) test, the first direct-to-consumer genetic screening test, according to a press release on Thursday, April 6.

FDA officials expect the product, which tests individuals for possible genetic predisposition for 10 diseases including Parkinson’s, late-onset Alzheimer’s, celiac disease, and hereditary hemochromatosis, to spur patients to consult with their physicians and make more informed lifestyle decisions.

The GHR test works by testing DNA from an individual’s saliva for more than 500,000 genetic variants. FDA officials warn that, while the test gives users a better idea of the odds of one of these diseases manifesting, it is not meant to be used as a diagnostic tool.

“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in the release. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”

The FDA has exempted all further GHR tests developed by 23andMe from premarket review, noting future GHR tests developed by other makers, excluding those used for diagnostic purposes, may also achieve this exemption after submitting their first premarket review.

For the full details, see the original announcement.

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