Although largely unregulated, genetic tests are increasingly used to diagnose conditions, map ancestry or predict disease risk. In this, the first of two related pieces, Arthur L. Beaudet advocates the US Food and Drug Administration banning direct-to-consumer medical tests but leaving the analysis of clinical diagnostics to specialists. In the second, Gail Javitt argues that the agency should implement a regulatory framework for all health-related tests.
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References
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm214671.htm
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm212830.htm
http://www.ncbi.nlm.nih.gov/projects/GeneTests/static/whatsnew/labdirgrowth.shtml
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http://www.eshg.org/fileadmin/www.eshg.org/documents/PPPC-ESHG-DTC-06122009.pdf
The Secretary's Advisory Committee on Genetics, Health, and Society. U.S. System of Oversight of Genetic Testing (US Dept Health & Human Services, 2008); available at http://oba.od.nih.gov/oba/SACGHS/reports/SACGHS_oversight_report.pdf
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Arthur L. Beaudet is in the Department of Molecular and Human Genetics at Baylor College of Medicine, which receives revenue from offering genetic laboratory testing.
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Beaudet, A. Which way for genetic-test regulation? Leave test interpretation to specialists. Nature 466, 816–817 (2010). https://doi.org/10.1038/466816a
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DOI: https://doi.org/10.1038/466816a
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