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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Sue Siegel is a member of Mohr Davidow, a Silicon Valley venture-capital firm, who are shareholders in Navigenics, Inc.
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Applying Preventive Genomic Medicine in Clinical Practice (Navigenics white paper)
Clinical Laboratory Improvement Amendments (CLIA)
Nature Reviews Genetics series on Translational Genetics
Organisation for Economic Co-operation and Development
Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS)
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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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