Cross-Border Genetic Testing

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Mar 22, 2010 - IVD Directive, but it should be restricted to laboratories accredited to ISO 15189 or equivalent standard. = mandatory accreditation for all rare.
Cross-Border Genetic Testing David Barton National Centre for Medical Genetics, Dublin, Ireland [email protected] 5th European Conference on Rare Diseases, Krakow, Poland

Questions • How much cross-border genetic testing is happening? • Why are samples sent across borders? • Does this create any problems? • What should we do about it?

OECD MGT Survey 2003: Main Conclusions 827 labs - 18 countries ≈ 1.1 million samples International exchange is widespread, particularly for rare disease testing. • 64% of labs received specimens from other countries • >18,000 samples crossed borders in 2002

• MGT is provided under widely varying conditions and regulatory frameworks

OECD MGT Survey 2003: Main Conclusions 827 labs - 18 countries ≈ 1.1 million samples Factors contributing to a high “Quality Score” (p