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Practical implementation of the German Genetic Diagnostics Act (GenDG) in Laboratory Medicine, the Human Genetics Laboratory and Genetic Counselling1)

  • Matthias Orth , Imma Rost , Georg F. Hoffmann and Hanns-Georg Klein
Published/Copyright: January 1, 2012
LaboratoriumsMedizin
From the journal LaboratoriumsMedizin Volume 35 Issue 5

Abstract

The German Genetic Diagnostics Act (GenDG) in its current version, effective since February 2010, has far-reaching consequences for all physicians and also for many patients. After more than 1 year of experience working with the GenDG, much of the previous criticism has proved to be inadequate. From the beginning, experts complained that besides the direct analysis of germline DNA, gene products should not be included in the scope of the act – potentially having a very broad impact on the entire in vitro diagnostics field. Problems with applying the act range from the impossibility of distinguishing between genetic and non-genetic examinations to enormous bureaucratic hurdles, which in some areas interfere with an efficient, state-of-the-art patient care (i.e., newborn screening, treatment with blood products). The rapid progress in technology, which is currently revolutionizing genetic diagnostics worldwide, has been set with narrow boundaries by the German GenDG, while at the same time “personalised medicine”, applying exactly the same technologies, is being funded by government research grants. From the viewpoints of the concerned physicians and patients, there is an urgent need to amend the act itself, and efficient action should be taken by the committee on genetic diagnostics (GEKO), which was appointed to define guidelines for the practical use of the GenDG.

Keywords: Committee on genetic diagnostics; DNA diagnostics; GEKO; genetic diagnostics; genetic diagnostics act; inherited diseases; newborn screening
Correspondence: Dr. med. Hanns-Georg Klein, Zentrum für Humangenetik und Laboratoriumsmedizin, Dr. Klein und Dr. Rost Medizinisches Versorgungszentrum GbR, Lochhamer Strasse 29, 82152 Martinsried, Germany. Tel.: +89 895578-0 Fax: +89 895578-780
Published Online: 2012

©2012 by Walter de Gruyter Berlin Boston

Articles in the same Issue

  1. Editorial/Leitartikel
  2. Molekulargenetische und zytogenetische Diagnostik
  3. Molekulargenetitsche und zytogenetische Diagnostik/Molecular-Genetic and Cytogenetic Diagnostics
  4. Implikationen des Gendiagnostikgesetzes (GenDG) für die Laboratoriumsmedizin/Implications of the German Human Genetic Examination Act on laboratory medicine
  5. Implications of the German Human Genetic Examination Act on laboratory medicine1),2),3)
  6. Praktische Umsetzung des Gendiagnostikgesetzes (GenDG) in der Laboratoriumsmedizin, dem humangenetischen Laboratorium und der humangenetischen Beratung/Practical Implications of the German Genetic Diagnostics Act (GenDG) for Laboratory Medicine, the Human Genetics Laboratory and for Genetic Counseling
  7. Practical implementation of the German Genetic Diagnostics Act (GenDG) in Laboratory Medicine, the Human Genetics Laboratory and Genetic Counselling1)
  8. Die Gendiagnostikkommission (GEKO), ein Instrument mit Richtlinienkompetenz/The German Gene Diagnostics Commission (GEKO): an instrument with guideline competence
  9. Gastkommentar Gendiagnostikgesetz (GenDG) und Patientenversorgung/Law for Genetic Diagnostic-Procedures (GenDG) in Germany: Guest Editorial
  10. Hämatologie/Hematology
  11. Lymphozytenmorphologie im Blutausstrich – Vorstellung einer überarbeiteten Nomenklatur und Systematik/Lymphocyte morphology in the peripheral blood film: proposal of a revised nomenclature and systematics
  12. 10.1515/JLM.2011.037et
  13. Die Bestimmung der freien Leichtketten (FreeliteTM) und der Immunglobulin-Kappa/Lambda-Subtypen (HevyliteTM) in der Diagnostik von Plasmazell-Erkrankungen/Serum free light chain and heavy/light chain analysis in patients with monoclonal gammopathy
  14. Labormanagement/Laboratory Management
  15. Wissensmanagement im Labor oder wie man Wissen erfolgreich als Ressource nutzt/Knowledge management in the laboratory or how knowledge can successfully be used as a resource
  16. 10.1515/jlm.2011.040et
  17. Helfen diagnostische Pfade das ökonomische Ergebnis eines Krankenhauses zu verbessern? Eine Betrachtung aus Sicht der Laboratoriumsmedizin/Do diagnostic pathways contribute to economic improvement of a hospital? Considerations from the perspective of laboratory medicine
  18. Do diagnostic pathways contribute to the economic improvement of a hospital? Considerations from the perspective of laboratory medicine1)
  19. Kongressbericht/Congress Report
  20. Die Entwicklung der Klinischen Chemie und Laboratoriumsmedizin des 20. Jahrhunderts am Beispiel des Klinikums Mannheim/Development of Clinical Chemistry and Laboratory Medicine in the 20th Century. The University Hospital Mannheim as an Example
  21. Jahrestagungsbericht/Annual Meeting Report
  22. Die Molekulare Diagnostik wird erwachsen: Bericht über die Zehnte Jahrestagung der Sektion Molekulare Diagnostik der DGKL in Tutzing/Molecular diagnostics comes of age: the 10th Annual Meeting of the Molecular Diagnostics Section of the German Society of Clinical Chemistry and Laboratory Medicine
  23. Buchbesprechung/Book Review
  24. Clinical Laboratory Investigation and Psychiatry A practical handbook
  25. Ankündigung/Announcement
  26. Ankündigung/Announcement
https://doi.org/10.1515/jlm.2011.045et
Keywords for this article
Committee on genetic diagnostics; DNA diagnostics; GEKO; genetic diagnostics; genetic diagnostics act; inherited diseases; newborn screening

Articles in the same Issue

  1. Editorial/Leitartikel
  2. Molekulargenetische und zytogenetische Diagnostik
  3. Molekulargenetitsche und zytogenetische Diagnostik/Molecular-Genetic and Cytogenetic Diagnostics
  4. Implikationen des Gendiagnostikgesetzes (GenDG) für die Laboratoriumsmedizin/Implications of the German Human Genetic Examination Act on laboratory medicine
  5. Implications of the German Human Genetic Examination Act on laboratory medicine1),2),3)
  6. Praktische Umsetzung des Gendiagnostikgesetzes (GenDG) in der Laboratoriumsmedizin, dem humangenetischen Laboratorium und der humangenetischen Beratung/Practical Implications of the German Genetic Diagnostics Act (GenDG) for Laboratory Medicine, the Human Genetics Laboratory and for Genetic Counseling
  7. Practical implementation of the German Genetic Diagnostics Act (GenDG) in Laboratory Medicine, the Human Genetics Laboratory and Genetic Counselling1)
  8. Die Gendiagnostikkommission (GEKO), ein Instrument mit Richtlinienkompetenz/The German Gene Diagnostics Commission (GEKO): an instrument with guideline competence
  9. Gastkommentar Gendiagnostikgesetz (GenDG) und Patientenversorgung/Law for Genetic Diagnostic-Procedures (GenDG) in Germany: Guest Editorial
  10. Hämatologie/Hematology
  11. Lymphozytenmorphologie im Blutausstrich – Vorstellung einer überarbeiteten Nomenklatur und Systematik/Lymphocyte morphology in the peripheral blood film: proposal of a revised nomenclature and systematics
  12. 10.1515/JLM.2011.037et
  13. Die Bestimmung der freien Leichtketten (FreeliteTM) und der Immunglobulin-Kappa/Lambda-Subtypen (HevyliteTM) in der Diagnostik von Plasmazell-Erkrankungen/Serum free light chain and heavy/light chain analysis in patients with monoclonal gammopathy
  14. Labormanagement/Laboratory Management
  15. Wissensmanagement im Labor oder wie man Wissen erfolgreich als Ressource nutzt/Knowledge management in the laboratory or how knowledge can successfully be used as a resource
  16. 10.1515/jlm.2011.040et
  17. Helfen diagnostische Pfade das ökonomische Ergebnis eines Krankenhauses zu verbessern? Eine Betrachtung aus Sicht der Laboratoriumsmedizin/Do diagnostic pathways contribute to economic improvement of a hospital? Considerations from the perspective of laboratory medicine
  18. Do diagnostic pathways contribute to the economic improvement of a hospital? Considerations from the perspective of laboratory medicine1)
  19. Kongressbericht/Congress Report
  20. Die Entwicklung der Klinischen Chemie und Laboratoriumsmedizin des 20. Jahrhunderts am Beispiel des Klinikums Mannheim/Development of Clinical Chemistry and Laboratory Medicine in the 20th Century. The University Hospital Mannheim as an Example
  21. Jahrestagungsbericht/Annual Meeting Report
  22. Die Molekulare Diagnostik wird erwachsen: Bericht über die Zehnte Jahrestagung der Sektion Molekulare Diagnostik der DGKL in Tutzing/Molecular diagnostics comes of age: the 10th Annual Meeting of the Molecular Diagnostics Section of the German Society of Clinical Chemistry and Laboratory Medicine
  23. Buchbesprechung/Book Review
  24. Clinical Laboratory Investigation and Psychiatry A practical handbook
  25. Ankündigung/Announcement
  26. Ankündigung/Announcement
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