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Annu Rev Genomics Hum Genet. 2008;9:161-82. doi: 10.1146/annurev.genom.9.081307.164319.

The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues.

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Department of Social Sciences, Loughborough University, Loughborough LE11 3TU, United Kingdom.


This review surveys the developing market for direct-to-consumer (DTC) genetic tests and examines the range of companies and tests available, the regulatory landscape, the concerns raised about DTC testing, and the calls for enhanced oversight. We provide a comparative overview of the situation, particularly in the United States and Europe, by exploring the regulatory frameworks for medical devices and clinical laboratories. We also discuss a variety of other mechanisms such as general controls on advertising and consumer law mechanisms.

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