Molecular diagnostics
Human genetic testing centre gains international quality accreditation.
IntegraGen, which develops genetic tests for complex diseases, has received accreditation, under ISO Standard 17025, to perform human genetic analyses at its German Competence Centre, in Bonn.
The centre was among the first to introduce diagnostic sequencing into human genetics, according to Jorg Leenings, Head of Sales and Marketing.
Screening for genetic predisposition to complex diseases that might lead to future illness could result in more effective personalised prevention programmes and treatments, Dr Jan Mous, President and CEO of IntegraGen, points out, adding that early and accurate genetic diagnosis of chronic conditions, such as diabetes, combined with genetic counselling services can also ensure patients are fully informed about their conditions.
Genes for most monogenic hereditary forms of diabetes have been identified. IntegraGen’s tests for these include MODY (maturity onset diabetes of the young); mitochondrial diabetes; neonatal diabetes, and congenital hyperinsulinism. IntegraGen also reports that it is developing a number of additional tests for other genes linked to the development of diabetes.
ISO 17025 is an international standard that assesses the technical competency of laboratories and helps to ensure accurate data generation, controlled test methods and procedures, and properly trained personnel. It covers all aspects of laboratory management, including sample preparation, analytical testing proficiency, report generation and record keeping. The IntegraGen accreditation was awarded by DAP GmbH (Deutsches Akkreditierungssystem Prüfwesen).
With 34 employees, IntegraGen has facilities in Bonn and in the French biotech park Genopole of Evry, near Paris.