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The future of direct-to-consumer clinical genetic tests

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Abstract

In light of the meeting of the US Food and Drug Administration (FDA) in March 2011 to discuss the regulation of clinical direct-to-consumer (DTC) genetic tests, we have invited five experts to consider the best means of overseeing the ordering and interpretation of these tests. Should these tests be regulated? If so, who, if anyone, should communicate results to consumers?

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Acknowledgements

R.C.G. would like to acknowledge funding from the National Human Genome Research Institute of the National Institutes of Health.

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Authors and Affiliations

  1. Felix W. Frueh is at the Medco Research Institute, Medco Health Solutions, Inc., 7315 Wisconsin Ave. Ste 1050E, Bethesda, Maryland 20814, USA.,

    Felix W. Frueh

  2. Henry T. Greely is at the Stanford Law School, Crown Quadrangle, 559 Nathan Abbott Way, Stanford, California 94305-8610, USA.,

    Henry T. Greely

  3. Division of Genetics, Department of Medicine, Robert C. Green is at the Partners Center for Personalized Genetic Medicine, Brigham and Women's Hospital and Harvard Medical School, 41 Avenue Louis Pasteur, Suite 301, Boston, Massachusetts 02115, USA.,

    Robert C. Green

  4. Department of Political Economy, Stuart Hogarth is at the Global Biopolitics Research Group, King's College London, Strand Campus, London WC2R 2LS, UK.,

    Stuart Hogarth

  5. Sue Siegel is at Mohr Davidow, 3000 Sand Hill Road, 3-290 Menlo Park, California 94025, USA.,

    Sue Siegel

Authors
  1. Felix W. Frueh
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  2. Henry T. Greely
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  3. Robert C. Green
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  4. Stuart Hogarth
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  5. Sue Siegel
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Corresponding authors

Correspondence to Felix W. Frueh, Henry T. Greely, Robert C. Green, Stuart Hogarth or Sue Siegel.

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Competing interests

Sue Siegel is a member of Mohr Davidow, a Silicon Valley venture-capital firm, who are shareholders in Navigenics, Inc.

Related links

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FURTHER INFORMATION

Felix W. Frueh's homepage

Henry T. Greely's homepage

Robert C. Green's homepage

Stuart Hogarth's homepage

Sue Siegel's homepage

A Common Framework of Principles for Direct-to-Consumer Genetic Testing Services (Human Genetics Commission document)

Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes

Applying Preventive Genomic Medicine in Clinical Practice (Navigenics white paper)

Clinical Laboratory Improvement Amendments (CLIA)

Human Genetics Commission

Nature Reviews Genetics series on Translational Genetics

Organisation for Economic Co-operation and Development

Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS)

Secretary's Advisory Committee on Genetic Testing (SACGT)

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Frueh, F., Greely, H., Green, R. et al. The future of direct-to-consumer clinical genetic tests. Nat Rev Genet 12, 511–515 (2011). https://doi.org/10.1038/nrg3026

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