ANRV353-GG09-09 ARI 30 July 2008 4:18 ANNUAL The Current Landscape for REVIEWS Further Click here for quick links to Annual Reviews content online, Direct-to-Consumer Genetic including: • Other articles in this volume Testing: Legal, Ethical, and • Top cited articles • Top downloaded articles • Our comprehensive search Policy Issues Stuart Hogarth,1 Gail Javitt,2 and David Melzer3 1Department of Social Sciences, Loughborough University, Loughborough LE11 3TU, United Kingdom; email:
[email protected] 2Genetics and Public Policy Center, Johns Hopkins University, Washington, DC 20036; email:
[email protected] 3Epidemiology and Public Health Group, Peninsula Medical School, Exeter EX2 5DW, United Kingdom; email:
[email protected] by University of California - Berkeley on 04/14/09. For personal use only. Annu. Rev. Genom. Human Genet. 2008.9:161-182. Downloaded from arjournals.annualreviews.org Annu. Rev. Genomics Hum. Genet. 2008. 9:161–82 Key Words The Annual Review of Genomics and Human Genetics personalized genomics, government regulation, DNA profiling is online at genom.annualreviews.org This article’s doi: Abstract 10.1146/annurev.genom.9.081307.164319 This review surveys the developing market for direct-to-consumer Copyright c 2008 by Annual Reviews. (DTC) genetic tests and examines the range of companies and tests All rights reserved available, the regulatory landscape, the concerns raised about DTC 1527-8204/08/0922-0161$20.00 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 clini- cal laboratories.