This article appears in the following Human Molecular Genetics issue: Association Studies [View the issue table of contents]
The regulation of direct-to-consumer genetic tests
Wellcome Trust Research Fellow, Ethox Centre, University of Oxford, Badenoch Building, Old Road Campus, Headington, Oxford OX3 7LG, UK
* To whom correspondence should be addressed. Tel: +44 1865287898; Fax: +44 1865287884; E-mail: jane.kaye{at}ethox.ox.ac.uk
Received July 8, 2008; Revised July 31, 2008; Accepted August 18, 2008
The past year has been marked by the emergence of several companies, such as 23andMe, deCODEME, Navigenics and Knome, offering tests using genome-wide technology direct to consumers over the internet. On the basis of the published research findings of GWAS and other studies, these companies will calculate an individual's risk to a number of common diseases, without the necessity of going through a medical practitioner. One of the significant challenges of direct-to-consumer testing is that it shifts the control of genetic testing from the clinical domain and medical professionals into the hands of consumers. No longer is genetic testing being carried out solely for medical reasons, by specialists in clinical genetics. Testing is now being used to empower consumers and can be used ‘to shed new light on your distant ancestors, your close family and most of all, yourself’ (23andMe). Such information can be shared with family and friends for ‘fun’, as part of the new ‘recreational genomics’. Direct-to-consumer testing challenges many of the assumptions that underpin current practice surrounding genetic tests while at the same time exposing the deficiencies in the current regulatory frameworks to regulate this area. The purpose of this paper is to explore some of these issues, at a time when the science and the law are changing rapidly.
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  J.C. Knight Genetics and the general physician: insights, applications and future challenges QJM, November 1, 2009; 102(11): 757 - 772. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 E. Edelman and C. Eng A practical guide to interpretation and clinical application of personal genomic screening BMJ, October 29, 2009; 339(oct29_3): b4253 - b4253. [Full Text]
|
|
|
|
 |
|
 B. Ameer and N. Krivoy Direct-to-Consumer/Patient Advertising of Genetic Testing: A Position Statement of the American College of Clinical Pharmacology J. Clin. Pharmacol., August 1, 2009; 49(8): 886 - 888. [Full Text] [PDF]
|
|