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The future of direct-to-consumer clinical genetic tests

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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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.

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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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  • DOI: https://doi.org/10.1038/nrg3026

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