, Volume 40, Issue 1, pp 113-117
Date: 13 Feb 2008

Regulatory Issues for Genetic Testing in Clinical Practice

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Abstract

Whereas deliver of health care is nationally based with great differences in ways of service provision and financing between countries, and thus not subject to international regulations, genetic testing has become more exposed to international regulations and conventions. This is due to an interest of protecting the individual for abuse by inappropriate use of genetic information, but also to the fact that a specimen from a person aimed for a medical (clinical genetic) test is considered as “tradable goods”, and thus also subject to other non-medical associated regulations. There is a substantial transborder flow of samples for genetic testing thus requiring internationally accepted quality standards. Therefore, laboratories acting on an international market need to follow certain rules and regulations, also applicable to obtain high-quality standards nationally. Further, genetic testing for rare disorders is often provided by a limited number of non-commercial laboratories and associated with research programs for the individual disorders. International surveys have revealed that there is a general lack of high standards for quality assurance. This article is aimed to give an introduction and overview of regulations, conventions, and quality standards applicable for the laboratory who is seeking to improve there quality performance.

This article is based on a previously published chapter in Methods in Molecular Medicine, vol. 92: Molecular Diagnosis of Genetic Diseases, Second Edition Edited by: R. Elles and R. Mountford, 2003© Humana Press Inc., Totowa, NJ, updated Jan 2008.