Food and Drug Administration

What the new, FDA-approved 23andMe genetic health risk reports can, and can't, tell you

What the new, FDA-approved 23andMe genetic health risk reports can, and can't, tell you

Genetic testing firm 23andMe got approval from the Food and Drug Administration last week to sell reports that show customers whether they have an increased genetic risk of developing certain diseases and conditions.

The go-ahead is the first time the federal agency has approved such direct-to-consumer genetic tests and comes about three years after the FDA warned Mountain View, Calif.-based 23andMe to stop marketing its health reports because they lacked agency authorization.

The company removed health-related results from its genetic tests after this warning, providing only ancestry information and raw genetic data without interpretation.

This time around, the FDA said...

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