9 July 2012
A new report makes recommendations for policy makers on the regulation of direct-to-consumer (DTC) genetic testing in the European Union.
The work is the outcome of a first joint project between the European Academies Science Advisory Council (EASAC) and the Federation of European Academies of Medicine (FEAM), two bodies tasked with fostering cooperation between the scientific academies of EU member states and providing consensus advice to policy makers.
Recent rapid advances in DNA analysis have led to a growth in DTC genetic tests available via the internet, raising many scientific and ethical questions and leading to potential confusion and distress for consumers.
The report cautions that current DTC genetic testing has little clinical value and advises against its use, particularly for serious highly-penetrant disorders, for the purposes of nutrigenomic and pharmacogenetic testing, and for prenatal screening and the testing of minors.
It emphasises that in order for a test to have any utility, quality standards in many areas need to be met. In particular, the claimed link between a genetic marker and a disease must be proven and the test’s interpretation of results scientifically validated, along with assurances of truthful advertising, adequate provision of counselling, and proper processes for seeking consent and maintaining privacy.
The report was prepared in consultation with an independent expert Working Group comprised of members from 11 EU countries. Its recommendations are directed primarily at policy makers at the EU level, but may also aid policy development within individual member states. PHG Chairman Ron Zimmern, the UK member of the Working Group, said of the report's findings "I think that what we have produced is a sensible and balanced approach that will inform European policy on these issues". The full report is available on the EASAC website.