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Commission on Genetic Testing

Members of the Commission on Genetic Testing. Source: © RKI

The Commission on Genetic Testing (GEKO) is an interdisciplinary, independent commission based on the Act on Genetic Testing (Gendiagnostikgesetz; GenDG). This act, effective since February 2010, stipulates the requirements of good practice with regard to safety, informed consent and free decision-making for people undergoing genetic testing. It contains general provisions and definitions for gene tests and regulates genetic examinations for medical purposes, for parentage and descent matters and genetic testing in insurance and employment sectors. The act does not cover tumour genetic diagnostics. Nor does it apply to genetic examinations and genetic analyses or the handling of genetic samples or gathering genetic data for research purposes.

The GEKO, established in November 2009 by the German Federal Ministry of Health, is made up of 18 members and 18 deputy members:

  • 13 experts from the specialties of medicine and biology
  • two experts from the areas of ethics and law
  • three representatives of nationally relevant organisations responsible for protecting the interests of patients, consumers and self-help institutions of the disabled.

The commission is mainly responsible for the preparation and issuance of guidelines (§ 23 GenDG) and written opinions to novel genetic screenings. Guidelines focus on professional and qualitative requirements for the performance of genetic analyses for medical and ancestry disclosure purposes. Every three years, GEKO has the mandate to evaluate new developments in genetic diagnostics in an activity report.

Date: 14.06.2016