Urgent regulation needed for direct to public gene tests, say experts

A new report - 'More Genes Direct' - published by the UK's Human Genetics Commission (HGC) called for tighter regulation and a review of the European Law which deals with genetic tests. The report - an update of the 2003 version - aims to address growing concerns over the number of genetic tests being sold directly to the public in the UK.

HGC Chair Sir John Sulston, also known for his pioneering work on the Human Genome Project, said that the potential for the results of such tests to be misinterpreted by patients was of particular concern. 'There is no doubt that many tests provided without the involvement of a doctor or a health professional could cause people totally unnecessary alarm or give them false reassurance. We have a burgeoning industry here and we urgently need regulation to match'.

Report author Dr Christine Patch, a Consultant Genetics Counsellor at Guy's and St Thomas' hospital in London, stressed her view that genetic tests should only be administered by a health professional. 'You need to offer full information on what it might mean and what you can do with the results. You need pre- and post- test counselling', she told the BBC.

Recent years have seen a boom in the number of companies providing genetic tests for a wide range of different diseases, including those for identifying certain types of cancer, such as breast cancer, and risk factors for common diseases, such as diabetes and heart disease. Although scientists now know that many diseases are the result of complex interactions between different combinations of genes and environment, many commercial tests look at only one or two gene variants, leading some critics to believe that, for the moment at least, such tests are not yet robust.

'People need to be aware of what they are buying', said Dr Patch in an HGC statement. 'My simple advice to the public is that, with many of the tests currently on the market, you are wasting your money. At the moment the science is not strong enough to be offering tests of multiple genes'.

The report stresses the urgent need for a regulatory framework fit for purpose, including changes to European law to bring in a requirement for direct to public genetic tests to be independently reviewed. Stuart Hogarth, an expert on regulation of genetic tests from the University of Nottingham, said that Europe was lagging dangerously behind in the development of standards for the regulation of genetic testing. The US, Canada and Australia all have tougher regulation for genetic tests than Europe, he highlighted to the BBC.