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Title:23andMe, the Food and Drug Administration, and the Future of Genetic Testing
Author(s):Zettler, Patricia J.; Sherkow, Jacob S.; Greely, Henry T.
Subject(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.
Issue Date:2014-03-01
Publisher:JAMA Internal Medicine
Citation Info: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)
Genre:Article
Type:Text
Language:English
URI:http://hdl.handle.net/2142/111002
DOI:10.1001/jamainternmed.2013.14706
Date Available in IDEALS:2021-09-24


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