The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues - PubMed (original) (raw)
Review
The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues
Stuart Hogarth et al. Annu Rev Genomics Hum Genet. 2008.
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.
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