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Health, including poverty-related diseases

Quality assurance in genetic testing

Background description

Requests for genetic tests have increased significantly over recent years. Genetic testing is an example of leading-edge research with exciting possibilities for diagnostic, predictive, preventive and forensic medicine. Unfortunately, genetic services suffer from frequent errors and variable reporting. One could blame the multiplication of tests made available, while structuring and harmonisation in Europe is needed. Test methods vary from country to country and are often used in a different country from the one where the test was performed. Yet there are no standards to ensure that the techniques are comparable. National legislation about disclosure of results also varies. The Commission has established an informal working group involving officials and experts from Member States to ensure exchange of information and best practice, as well as to identify actions which should be addressed at EU level in order to assure the highest quality of genetic testing. A survey on national legislations and activities regarding genetic testing has been prepared (http://europa.eu.int/comm/research/biosociety/pdf/bioethics-survey-test2106.pdf). Citizens need to be assured that genetic testing is reliable, consistent and of the highest quality, and that its results will always be used responsibly.

Profile

EuroGentest is a Network of Excellence, involving 34 partners in 18 different countries, set up under the Sixth Framework Programme to focus on the issues of harmonisation, validation and standardisation of genetic tests. It aims at improving the organisation and harmonisation of external quality assessment/assurance schemes, at facilitating the development of guidelines, and at supporting the accreditation/certification of genetic services. The network tries to bridge a gap between research and diagnostics applications. It also intends to collect tools for the education of various stakeholders and to improve the quality of genetic counselling services. Special attention is given to the principles of medical ethics and the ethical issues raised by the use of genetics tests, such as confidentiality, informed consent, employment and insurance.

Full project title: Genetic Testing in Europe - Network for test development, standardisation, harmonisation and validation
Project acronym: EuroGentest
EU funding: €10 million
Project launch: 1 January 2005
Duration: 60 months
Project coordinator: Jean-Jacques Cassiman, Centre for Human Genetics, Leuven, Belgium
Website
European Commission contact person: Jean-Luc Sanne

Science in society significance

Genetic testing is of concern to citizens in relation to their health and work. Genetic testing for rare and complex diseases affects the whole family. Tests are now available for over 1 000 different conditions. A growing number of laboratories in Europe and across the world are offering a wide and varied array of genetic testing and analysis services. These practices are becoming increasingly frequent, highly variable in quality, and available across national boundaries. Some genetic tests are becoming subject to uncontrolled ‘mass marketing’, including via the internet. EU-wide networking and the sharing of information will lead the way to quality assurance for genetic tests, reassuring people being tested and their families.

The European Group on Ethics in Science and New Technologies has considered the protection of workers’ personal data in the workplace, recommending that the confidentiality of genetic data be preserved even when workers move from one country to another. Genetic testing could also impact personal health insurance. Education and training in genetic testing will be evaluated and quality criteria defined.

In order to stimulate the debate on genetic testing, in 2003 the Commission established a high-level expert group, chaired by Eryl McNally, then Member of the European Parliament. This group, which included scientists, lawyers, ethicists, patient organisations and representatives from industry, gave 25 recommendations on how genetic testing can be used in a responsible and ethical way.

Expected results/outcomes

  • Guidelines for quality assurance and harmonisation of genetic testing;
  • Development of a common range of certified reference materials;
  • Better cross-border co-operation;
  • European database of genetic testing centres;
  • EU-wide network of national centres;
  • Database on education initiatives and survey report on information materials.

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