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

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


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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Advertising
  • Europe
  • Genetic Techniques / economics
  • Genetic Techniques / ethics*
  • Genetics, Medical / economics
  • Genetics, Medical / ethics*
  • Genetics, Medical / legislation & jurisprudence*
  • Humans
  • Marketing of Health Services
  • Public Policy
  • United States