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Innovation, Risk, and Patient Empowerment:  The FDA-Mandated Withdrawal of 23andMe’s Personal Genome Service

Nicholas S. Downing, AB1; Joseph S. Ross, MD, MHS2
[+] Author Affiliations
1Yale University School of Medicine, New Haven, Connecticut
2Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut
JAMA. 2014;311(8):793-794. doi:10.1001/jama.2014.148.
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On November 22, 2013, the US Food and Drug Administration (FDA) took the surprising step of ordering 23andMe, a genomics company, to cease marketing its flagship Personal Genome Service (PGS). The PGS is a DNA sequencing product marketed directly to consumers that claims to “help individuals and their doctors identify health areas that they need to keep an eye on.” By determining the presence of certain single-nucleotide polymorphisms, the PGS estimates risk for more than 250 diseases and health conditions by extrapolating from research studies. After initially continuing to sell its product, 23andMe heeded the FDA’s warning letter and stopped offering health-related genetic tests on December 6, 2013.

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