Biotechnology policies

OECD Guidelines for Quality Assurance in Genetic Testing


OECD member countries have adopted an agreed set of Guidelines for Quality Assurance in Molecular Genetic Testing. The Guidelines address genetic testing for variations in germ line DNA sequences or products arising directly from changes in heritable genomic sequences that predict effects on the health, or influence the health management, of an individual. They focus on molecular genetic testing for the diagnosis of a particular disease or condition and predictive genetic testing often carried out before any clinical signs of the disease or condition appear. They are relevant to tests for heritable DNA variants that predict the response profile of an individual to a drug or course of therapy and that affect susceptibility to disease, patient prognosis, counselling, treatment and family planning. They do not address testing carried out only for research purposes.



Related Documents


Genetic Testing: A Survey of Quality Assurance and Proficiency Standards

OECD Summary Report of a Large-Scale Survey on Molecular Genetic Testing Laboratory Practices across 18 OECD Countries

OECD Workshop Vienna 2000 on Genetic Testing: Policy Issues for the New Millennium

to be changed

Directrices de la OECD para garantizar la Calidad de los Estudios Genéticos Moleculares