domingo, 22 de julio de 2012

Direct-to-consumer genetic testing : The Lancet

Direct-to-consumer genetic testing : The Lancet

The Lancet, Volume 380, Issue 9837, Page 76, 14 July 2012
doi:10.1016/S0140-6736(12)61159-3Cite or Link Using DOI

Direct-to-consumer genetic testing

2 years ago The Lancet warned of the lax regulation of direct-to-consumer genetic testing (DTC GT). Concerns remain over marketing, quality, counselling, interpretation, confidentiality, and follow-up costs. To provide a scientific basis for regulation of tests used in the European Union (EU), the European Academies Science Advisory Council and the Federation of European Academies of Medicine published a report on DTC GT on June 29. In the absence of evidence for benefit, the report recommends EU citizens do not use DTC GT. The authors advised against several types of test in particular, such as prenatal screening, testing children, tests on third parties, and tests for so-called nutrigenomics.
 
Developments in DTC GT respond to demands from intelligent populations used to internet services and autonomy, with which regulation must keep pace. Banning non-medical access to genetic tests, as does Germany, is not a practical solution; nor is the over-the-counter approach of Greece. Policy makers must balance potential, albeit uncertain, benefits against harm for different types of genetic test. Proactive, flexible, and workable responses are needed, which not only inform and protect consumers, but also encourage products that might add value. Moreover, regulations should not be based solely on today's concerns, such as interpretation of low-penetrance susceptibility loci for multifactorial diseases, but should consider future technical advances like affordable whole genome sequencing.
 
Direct-to-consumer pregnancy tests have empowered women, reduced the burden on health systems by rationalising services, and possibly improved outcomes by accelerating antenatal care or other interventions. DTC GT could similarly improve health by increasing individual awareness and enabling more personalised interventions. To realise the potential of DTC GT requires engagement between scientists and regulators to couple innovation with research that includes surveillance; improved genetic literacy for consumers and health-care providers; and well-supported genetic medicine services so that DTC GT does not occur in a vacuum.
 
For New guidelines for genetic tests are welcome but insufficient see Editorial Lancet 2010; 376: 488
For Direct-to-consumer genetic testing for health-related purposes in the European Union: the view from EASAC and FEAM see http://www.easac.eu/home/reports-and-statements/detail-view/article/direct-to-co.html

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