23andMe, the Food and Drug Administration, and the future of genetic testing

PJ Zettler, JS Sherkow, HT Greely - JAMA internal medicine, 2014 - jamanetwork.com
On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted
health-related directto-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. Since 2007, Mountain View, California …
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