University of Illinois Urbana-Champaign

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

Zettler, Patricia J.; Sherkow, Jacob S.; Greely, Henry T.

Permalink

https://hdl.handle.net/2142/111002

Description

Title
23andMe, the Food and Drug Administration, and the Future of Genetic Testing
Author(s)
  • Zettler, Patricia J.
  • Sherkow, Jacob S.
  • Greely, Henry T.
Issue Date
2014-03-01
Keyword(s)
  • 23andMe
  • genes
  • genetics
  • genetic testing
  • DTC
  • FDA
  • biotech
  • sequencing
  • DNA
  • health
  • law
  • science
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.
Publisher
JAMA Internal Medicine
Type of Resource
text
Language
en
Permalink
http://hdl.handle.net/2142/111002
DOI
10.1001/jamainternmed.2013.14706

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