OECD seeks comments on draft genetic testing quality assurance guidelines
The Organisation for Economic Co-operation and Development (OECD) is seeking comments on its draft Guidelines for Quality Assurance in Molecular Genetic Testing (see press release). The Guidelines set out principles and best practice for quality assurance in molecular genetic testing for clinical purposes. Specifically, they address diagnostic and carrier testing, as well as genetic testing to predict a person’s response to a drug or course of therapy (i.e. pharmacogenetic testing). The goal of the guidelines is to introduce procedures and best practice to ensure minimum international requirements for QA systems and laboratory practices across OECD countries, to facility mutual recognition of existing national or regional QA frameworks, strengthen international co-operation when testing and test information crosses borders and increase public confidence in the governance of molecular genetic testing.
In 2002 the OECD conducted a survey on the availability and extent of molecular genetic testing in the OECD member countries, as well as the quality assurance practices used in testing laboratories. Eighteen countries participated; a summary report was published in 2005 (see news story). The survey found that there has been a steady growth in molecular genetic testing and many countries had mechanisms in place to reduce risk from inappropriate or inaccurate testing, including licensing, accreditation and certification procedures. However, the OECD has determined that “…these regulatory and oversight procedures have not penetrated diagnostic molecular genetic testing laboratories across OECD countries to a high degree and with any consistency.” Therefore, “[a]s laboratories increasingly provide their services to both national and international customers, there is a need to develop international consensus and best practice to assure consistency in the quality of services available.” The draft Guidelines set out general principles and practices for molecular genetic testing and more specific recommendations for best practice for quality assurance systems, the monitoring of laboratory practices, quality reporting procedures, and the education and training of laboratory personnel.
Comments on the draft Guidelines are encouraged. The consultation is open until 4 September 2006. The OECD Member States will consider all comments during their final negotiations. The final Guidelines are due to be available in Spring 2007.