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The future of direct-to-consumer clinical genetic tests


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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  1. Green, R. C. et al. Disclosure of APOE genotype for risk of Alzheimer's disease. N. Engl. J. Med. 361, 245–254 (2009).

    CAS  Article  Google Scholar 

  2. Bloss, C. S., Schork, N. J. & Topol, E. J. Effect of direct-to-consumer genomewide profiling to assess disease risk. N. Engl. J. Med. 364, 524–534 (2011).

    CAS  Article  Google Scholar 

  3. McBride, C. M., Koehly, L. M., Sanderson, S. C. & Kaphingst, K. A. The behavioral response to personalized genetic information: will genetic risk profiles motivate individuals and families to choose more healthful behaviors? Annu. Rev. Public Health 31, 89–103 (2010).

    Article  Google Scholar 

  4. Marteau, T. M. et al. Effects of communicating DNA-based disease risk estimates on risk-reducing behaviours. Cochrane Database Syst. Rev. 2010, CD007275 (2010).

    Google Scholar 

  5. Zick, C. et al. Genetic testing for Alzheimer's disease and its impact on insurance purchasing behavior. Health Aff. (Millwood) 24, 483–490 (2005).

    Article  Google Scholar 

  6. Taylor, D. Jr et al. Genetic testing for Alzheimer's and long-term care insurance. Health Aff. (Millwood) 29, 102–108 (2010).

    Article  Google Scholar 

  7. Vernarelli, J. A. et al. Effect of Alzheimer's disease genetic risk disclosure on dietary supplement use. Am. J. Clin. Nutr. 91, 1402–1407 (2010).

    CAS  Article  Google Scholar 

  8. LaRusse, S. et al. Genetic susceptibility testing versus family history-based risk assessment: impact on perceived risk of Alzheimer disease. Genet. Med. 7, 48–53 (2005).

    Article  Google Scholar 

  9. Linnenbringer, E., Roberts, J., Hiraki, S., Cupples, L. & Green, R. “I know what you told me, but this is what I think:” perceived risk of Alzheimer disease among individuals who accurately recall their genetics-based risk estimate. Genet. Med. 12, 219–227 (2010).

    Article  Google Scholar 

  10. Helgadottir, A. et al. A common variant on chromosome 9p21 affects the risk of myocardial infarction. Science 316, 1491–1493 (2007).

    CAS  Article  Google Scholar 

  11. Samani, N. J. et al. Genomewide association analysis of coronary artery disease. N. Engl. J. Med. 357, 443–453 (2007).

    CAS  Article  Google Scholar 

  12. Mainous, A. G. et al. A coronary heart disease risk score based on patient-reported information. Am. J. Cardiol. 99, 1236–1241 (2007).

    Article  Google Scholar 

  13. Wilson, P. W. et al. Prediction of coronary heart disease using risk factor categories. Circulation 97, 1837–1847 (1998).

    CAS  Article  Google Scholar 

  14. Hudson, K. L. Genetic testing oversight. Science 313, 1853 (2006).

    CAS  Article  Google Scholar 

  15. Javitt, G. & Hudson, K. Federal neglect: regulation of genetic testing. Issues Sci. Technol. 22, 59–66 (2006).

    Google Scholar 

  16. Javitt, G., Katsanis, S., Scott, J. & Hudson, K. Developing the blueprint for a genetic testing registry. Public Health Genomics 13, 95–105 (2010).

    CAS  Article  Google Scholar 

  17. McGuire, A. & Burke, W. Raiding the medical commons: an unwelcome side effect of direct-to-consumer personal genome testing. JAMA 300, 2669–2671 (2008).

    CAS  Article  Google Scholar 

  18. Evans, J. P. & Green, R. C. Direct to consumer genetic testing: avoiding a culture war. Genet. Med. 11, 1–2 (2009).

    Article  Google Scholar 

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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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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

Related links


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).

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