Brussels, 25 Nov 2003
A new report by the Commission's Joint Research Centre (JRC) has raised concerns about the quality of genetic testing methods in the EU, and advocated an international approach to the issue to remedy the situation.
The use of genetic tests, used, for example, to predict the future onset of severe or hereditary disorders, is expanding throughout Europe. It is estimated that more than 700,000 tests are now carried out per year, with this figure set to rise sharply over the next decade.
The report states that because the technique has 'rapidly moved from the laboratory into medical use [...] issues of quality have not always been given sufficient attention.' Some data point to an error rate during testing of up to two per cent, described by the authors as 'unacceptable', and there is also evidence of misinterpretation of results.
However, the difficulty in finding comprehensive statistics on those organisations that carry out genetic tests in Europe leads the report to conclude that a first step to improving quality is the creation of a database containing such data. The database should be constantly updated, and include accreditation and quality assurance information for each laboratory listed.
European quality assurance (EQA) schemes are described as extremely successful in preventing errors, and the report recommends that such schemes should be encouraged and harmonised at a European level. The authors are quite clear, however, that the creation of a new, common scheme is not required.
The provision of proper counselling in genetic testing is considered 'of utmost importance,' but is far from guaranteed at the present time. Differences in the cost of genetic tests between Member States could eventually lead to problems, warns the report, but at present the disparity is not large.
The report speculates that the recommended European approach to these issues could take the form of a Network of Excellence under the current EU Framework Programme for research, at least in the short term: Regardless of the eventual structure of the overseeing body, solving these issues will 'require a significant coordination effort, long term funding, and it will strictly depend on voluntary codes of conduct,' the report concludes.
To read the JRC report, please consult the following web address: