Die Gendiagnostikkommission (GEKO), ein Instrument mit Richtlinienkompetenz

Few EU countries have passed legislations regulating medical genetic testing. In 2010, the German “Law on Genetic Testing in Humans” (GenDG) became active. It regulates laboratory diagnostic procedures in a comprehensive way to avert discrimination of citizens on the basis of genetic data. Specifica...

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Bibliographic Details
Main Author: Neumaier, Michael (Author)
Format: Article (Journal)
Language:German
Published: 1. September 2011
In: Laboratoriumsmedizin
Year: 2011, Volume: 35, Issue: 5, Pages: 255-257
ISSN:1439-0477
DOI:10.1515/JLM.2011.043
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1515/JLM.2011.043
Verlag, lizenzpflichtig, Volltext: https://www.degruyterbrill.com/document/doi/10.1515/JLM.2011.043/html
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Author Notes:Michael Neumaier

MARC

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520 |a Few EU countries have passed legislations regulating medical genetic testing. In 2010, the German “Law on Genetic Testing in Humans” (GenDG) became active. It regulates laboratory diagnostic procedures in a comprehensive way to avert discrimination of citizens on the basis of genetic data. Specifically, its definition of a genetic test encompasses - next to the number and structure of chromosomes - any other class of biomolecule, i.e., sequence and concentration of nucleic acids and their modified derivatives, proteins and in the case of metabolic diseases also the intermediary or final end products of biochemical pathways. This reflects the will of the legislator to uncouple the genetic question in medical diagnostics from the biomaterial substrate needed to be analyzed. To deal with the ramifications of this broad approach in everyday clinical medicine, §23 of the GenDG establishes the installation of the German Gene Diagnostics Commission (GEKO) to issue guidelines for the laboratory and clinical diagnostician. The GEKO is an interdisciplinary committee consisting of medical professionals as well as representatives from ethics and patients interest organizations. Furthermore, the German counties and professional healthcare organizations can send delegates as invited guests to GEKO plenary and working group meetings. This paper describes the set-up and operative work of the German GEKO commissioned to support medical genetic testing in compliance with current German legislation. 
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