The regulation of direct-to-consumer genetic tests

Human Molecular Genetics

Volumn 17, Issue R2, 2008, Pages

  Kaye, Jane ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ETHICS; GENETIC PREDISPOSITION; GENETIC PRIVACY; GENETIC SCREENING; HUMAN; LEGAL ASPECT; REVIEW; RISK ASSESSMENT; STANDARD;

GENETIC PREDISPOSITION TO DISEASE; GENETIC PRIVACY; GENETIC SCREENING; HUMANS; RISK ASSESSMENT;

EID: 58149327181     PISSN: 09646906     EISSN: 14602083     Source Type: Journal    
DOI: 10.1093/hmg/ddn253     Document Type: Article

References (26)

1. Wellcome Trust Case Control Consortium. (2007) Genome-wide association study of 14,000 cases of seven common diseases and 3,000 shared controls. Nature, 447, 661-678.
2. https://www.23andme.com/ (accessed 03/07/08)
3. http://www.decodeme.com/ (accessed 03/07/08)
4. http://www.navigenics.com/ (accessed 03/07/08)
5. http://www.knome.com/ (accessed 03/07/08)
6. In addition, there are companies that offer other kinds of tests such as using DNA to identify ancestry (Genetrack Biolabs http://www. dnaancestryproject.co; DNA Print Genomics http://www.danaprint.com; IBM/National Genographic Project http:/tinyurl.com/34ygbu); for personalised diet, lifestyle and nutrition (Mycellf www.sciona.com; Salugen http://www.salugen.com); individual responses to nicotine (G-nostics http://www.nicotest.com) and a dating service based on genes associated with the immune system (ScientificMatch.com http://www. scientificmatch.com); as well as testing for common diseases (DNATraits http://www.dnatraits.com/index.php/catalog).
7. Knome offers a whole genome scan for US$350,000, which places them out of the reach of the vast majority of consumers. Another company offering a similar service is DNADirect http://www.dnadirect.com/.
8. http://www.youtube.com/watch?v=F7UH0BBHhoj0 (accessed 03/07/08)
9. https://www.navigenics.com/genomics/Overview/ (accessed 03/07/08)
10. Lenzer, J. and Brownlee, S. (2008) Knowing me, knowing you. Br Med J, 336, 858-860.
11. https://www.navigenics.com/ (accessed 30/06/08)
12. https://www.23andme.com/about/consent/ (accessed 30/06/08)
13. In the information form for people registering to the site http://www. decodeme.com/ (accessed 03/07/08)
14. Hunter, D.J., Khoury, M.J. and Drazen, J.M. (2008) Letting the genome out of the bottle-will we get our wish? N Engl J Med, 358, 105-107.
15. Hendersen, M. (2008) Handle with care: genetic tests are risky, and I've got the proof. The Times, March 1.
16. Kaiser, J. (2007) It's all about me. Science, 318, 1843.
17. Foster, M.W. and Sharp, R.R., (2008) Out of sequence: how consumer genomics could displace clinical genetics. Nat Rev Gen, doi:10.1038/ nrg2374 (First published online15 April 2008).
18. While there are documents such as the OECD Guidelines for Quality Assurance in Molecular Genetic Testing 2007 that provide principles for policy guidance, much of the regulation is carried out at a national level
19. Hogarth, S. and Melzer, D. (2007) The IVD directive and genetic testing problems and proposals. A briefing presented to the 20th Meeting of Competent Authorities, Lisbon, July 2007; The regulatory framework for genomic tests - Evidence to the House of Lords Science and Technology Sub-Committee on Genomic Medicine, April 2008 http://www. parliament.uk/documents/upload/stGMHogarthandMelzer.pdf (accessed 03/07/08)
20. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices OJ L 331, 7.12.1998, p. 1-37.
21. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes http:// conventions.coe.int/Treaty/EN/Treaties/Html/TestGen.htm (accessed 03/ 07/08)
22. Art.6 Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes http:// conventions.coe.int/Treaty/EN/Treaties/Html/TestGen.htm (accessed 03/ 07/08)
23. Art. 8, 9, and 11 Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes http:// conventions.coe.int/Treaty/EN/Treaties/Html/TestGen.htm (accessed 03/ 07/08)
24. This Additional Protocol will only affect countries that have signed the Council of Europe Convention on Human Rights and Biomedicine 1997 ETS No. 164, of which a number of key countries within the Europe, such as the UK has not signed. Even for signatories of the Convention, it is still an optional protocol and will have to be implemented into national law to have full effect.
25. Katsanis, S.H., Javitt, G. and Hudson, K. (2008) A Case Study of Personalized Medicine. Science, 320, 53-54.
26. Wadman, M., (2008) Gene-testing firms face legal battle Nature, 453, 1148-1149 doi:10.1038/4531148a