The Current Landscape for Direct-to-Consumer Genetic Testing: Legal, Ethical, and Policy Issues
Top Cited Papers
- 1 September 2008
- journal article
- review article
- Published by Annual Reviews in Annual Review of Genomics and Human Genetics
- Vol. 9 (1) , 161-182
- https://doi.org/10.1146/annurev.genom.9.081307.164319
Abstract
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.Keywords
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