April 2014

23andMe, the Food and Drug Administration, and the Future of Genetic Testing

Author Affiliations
  • 1Center for Law and the Biosciences, Stanford University, Stanford, California

Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA Intern Med. 2014;174(4):493-494. doi:10.1001/jamainternmed.2013.14706

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing.1 The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.

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