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 come to a consensus about how to synchronize quality ass…