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Regulation: The FDA is overcautious on consumer genomics

Nature volume 505, pages 286–287 (2014)Cite this article

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A US drug-agency clampdown is unwarranted without evidence of harm, say Robert C. Green and Nita A. Farahany.

Since 2007, people have been able to spit in a tube, ship it to a company and later log on to a website to learn what their DNA reveals about non-medical traits such as hair texture and ancestry, as well as whether they carry DNA variants associated with increased risks for diseases including type 2 diabetes and Alzheimer’s. More than 500,000 people have bought such tests.

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Author information

Authors and Affiliations

  1. Robert C. Green is in the Division of Genetics, Brigham and Women’s Hospital and Harvard Medical School, and the Partners HealthCare Center for Personalized Genetic Medicine, Boston, Massachusetts.,

    Robert C Green

  2. Nita A. Farahany is at the Duke University School of Law and the Duke Institute for Genome Sciences and Policy, Durham, North Carolina.,

    Nita A Farahany

Authors
  1. Robert C Green
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  2. Nita A Farahany
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Competing interests

R.C.G. leads several NIH research projects on genetic disclosure including one completed project, the Impact of Personal Genomics or PGen Study, (R01-HG005092) Scientists from two companies, 23andMe and Pathway Genomics interact with this study but have no control over data, analysis or publications. R.C.G. has, without compensation, contributed self-scripted, non-exclusive educational material to the 23andMe website. R.C.G. has not received personal financial support from any of the above entities; he has received support from the Brin-Wojcicki Foundation for an unrelated sequencing project.

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Green, R., Farahany, N. Regulation: The FDA is overcautious on consumer genomics. Nature 505, 286–287 (2014). https://doi.org/10.1038/505286a

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