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February 26, 2014

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

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

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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