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Past Research Projects


Funder: 7th Framework Programme
Timeline: January 2011-January 2013
Investigators: S Hogarth and B Salter at King's College London

Molecular diagnosis of genetic diseases has rapidly moved from the laboratory into medical use and the quality issues have become more pressing. Genetic testing is offered internationally, through both public and private sector services, and there is evidence that human samples and related data are being exchanged across borders in an environment where regulatory and oversight procedures vary significantly between jurisdictions. This expanded use and “internationalisation” of genetic testing raises novel issues and is challenging the current regulatory frameworks governing genetic services. EuroGentest began as an FP6 European network for the harmonization of genetic testing and for the further improvement of quality in genetic services across Europe. It has received renewed funding under FP7. The Global Biopolitics Research Group had an informal collaborative relationship with EuroGentest under FP6 working together on policy issues relating to the regulatory framework for genetic tests in the European Union and is now a formal partner for EuroGentest’s FP7 programme helping to coordinate policy work.

The harmonisation of the quality of genetic testing services is an issue which concerns policymakers across the globe. The governance challenges raised by the globalisation of genetic testing requires coordinated action between national governments, industry and professional bodies and has been taken up by transnational agencies such as the OECD and the WHO.
EuroGentest made a significant contribution to this process, playing a role in the development of the OECD guidelines and the Council of Europe’s 2008 Protocol and developing links with bodies such as CDC in the US, APOGEE-Net/CanGèneTest (the Canadian Research and Knowledge Network on Genetic Health Services and Policy), the CLSI (Clinical and Laboratory Standards Institute) and EGAPP (Evaluation of Genomic Applications in Practice and Prevention) initiative.

Our work package will form a task force which will be responsible for the coordination of policy work on the development of new governance mechanisms and the updating of existing regulatory regimes. The task force will keep EUGT2 participants abreast of policy developments and work with professional societies, to shares EUGT2 expertise with policymakers in a range of EU and broader transnational policy fora creating an effective voice for the genetic centres. The task force will liaise with similar initiatives when invited to committees and work groups in the US, Canada and elsewhere, to promote global solutions.

For further information, please visit the EuroGentest website.
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