Case Study: European Union and Genetic Testing

Situation The European Union faces the dual challenge of developing adequate standards for genetic testing while bridging national, social, and linguistic differences. Accordingly, the best description of the current quality assurance situation in the European Union is one of fragmentation; national policies differ widely on areas such as requirements for laboratory accreditation, clinical genetic requirements, and novel genetic test evaluation. Given the number and diversity of countries in the EU, it is understandably difficult to …

…for genetic testing. Genetic testing as it currently exists may evolve to be very different in the future -- as tests for disease susceptibility for more complex disorders like diabetes and cancer become more prominent, regulation of genetic testing must remain dynamic to account for the rapid evolution of this field. Although current solutions must address current problems, these solutions must be dynamic enough to account for the evolving field of genetic testing and genomics.