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23andMe, the Food and Drug Administration, and the Future of Genetic Testing
JAMA Internal Medicine
  • Patricia J. Zettler, Georgia State University College of Law
  • Jacob S. Sherkow, Stanford University
  • Henry T. Greely, Stanford University
Document Type
Article
Publication Date
4-1-2014
Abstract

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. 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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Citation Information
Patricia J. Zettler, Jacob S. Sherkow, & Henry T. Greely, 23andMe, the Food and Drug Administration, and the Future of Genetic Testing, 174 JAMA Internal Med. 493 (2014).