Paris, 25 April 2005
This report presents recommendations for action to assure the quality of human genetic testing and the proficiency of those that carry out such tests. It provides the first detailed information about the availability and extent of molecular genetic testing throughout the OECD member countries as well as existing quality assurance practices in use in testing laboratories, including policies regarding samples and genetic data handling, and transborder flow of specimens. It also provides some insight into the level of proficiency of those offering genetic tests. It reports the results of a survey 18 OECD countries, with responses from 8 laboratory directors. The survey was carried out between June and October 2003 in Austria, Belgium, Canada, the Czech Republic, Finland, France, Germany, Ireland, Italy, Japan, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, the United Kingdom and the United States.
To guide the development and implementation of the survey, a steering group of experts and government representatives from the 18 participating countries was established (Annex B). Their work was invaluable and special thanks are due to Dr. Rob Elles (United Kingdom) who chaired the expert group and to Dr. Margaret McGovern, who acted as expert consultant to the OECD throughout the project. The financial support of Japan and of the European Commission is gratefully acknowledged. Dr. Elettra Ronchi of the OECD Secretariat was responsible for the co-ordination of this activity which took place under the supervision of the OECD Working Party on Biotechnology.