Specific regulation of laboratories performing molecular genetic tests are needed to ensure standards and quality assurance (QA) and safeguard patient rights to informed consent and confidentiality.
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.
OECD Guidelines for Quality Assurance in Molecular Genetic Testing in English
and French
OECD , 2007
Quality control in molecular genetic testing
Dequeker et al. , Nature Reviews Genetics, 2001, 2, 717-723
Genetic testing and quality control in diagnostic laboratories
Dequeker E, Cassiman J-J , Nature Genetics, 2000, 25, 259-260
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