Society – Diagnostics

Legal Issues

Understanding the legal and regulatory framework governing molecular pathology in Switzerland is crucial to ensuring compliance, quality, and patient safety. Below is an overview of the key legal aspects relevant to molecular pathology practice.

National Legislation – Federal Act on Human Genetic Testing (LAGH / GUMG)

In Switzerland, genetic analyses are governed by the Federal Act on Human Genetic Testing (LAGH / GUMG). This law outlines the conditions required to perform genetic testing, ensuring the protection of human dignity, preventing misuse of genetic information, and guaranteeing the accuracy and reliability of genetic analyses. The LAGH covers genetic testing in medical and non-medical contexts, including employment, insurance, parentage determination, and identity verification.

Laboratory Accreditation Standards

Swiss laboratories performing cytogenetic and molecular genetic analyses for medical purposes must obtain authorization from the Federal Office of Public Health (OFPS / BAG). This authorization requires accreditation according to recognized international standards, specifically ISO 15189, which establishes quality and competence requirements for medical laboratories.

Accreditation is supervised and regularly audited by the Swiss Accreditation Service (SAS), ensuring that laboratories maintain high standards in their analytical procedures.

Confidentiality and Patient Rights

The LAGH/GUMG emphasizes the rights of individuals undergoing genetic tests:

Informed Consent: Genetic analyses can only be conducted with the explicit and informed consent of the individual tested. For minors, consent must be provided by their legal guardians.
Data Protection: Genetic data and samples must be securely handled to protect patient confidentiality. Unauthorized access or use of genetic information is strictly prohibited.

International Considerations

While Swiss regulations primarily guide local practice, Swiss molecular pathology laboratories also align with international best practices and guidelines. This facilitates international cooperation, ensures quality standards, and supports cross-border research initiatives.

For further details or updates on legal and regulatory matters, please consult the official resources provided by the Federal Office of Public Health (OFSP/BAG) and the Swiss Accreditation Service (SAS).

Recommendations of SSMP

A summary of the Society’s official diagnostic recommendations: recognized guidelines, practice standards, and validated protocols that ensure reliable, high-quality molecular analyses.

Reporting of somatic variants in clinical cancer care: recommendations of the SSMolPath

NGS-based somatic variant testing is now standard in Swiss cancer diagnostics, but wide variability in reporting has led the Swiss Society of Molecular Pathology to launch national consensus recommendations to standardize clinically comprehensive, interpretable reports for all stakeholders.

Virchows Arch . 2024 Dec;485(6):1033-1039.

Yann Christinat, Baptiste Hamelin, Ilaria Alborelli, Paolo Angelino, Valérie Barbié, Bettina Bisig, Heather Dawson, Milo Frattini, Tobias Grob, Wolfram Jochum, Ronny Nienhold, Thomas McKee, Matthias Matter, Edoardo Missiaglia, Francesca Molinari, Sacha Rothschild, Anna Bettina Sobottka-Brillout, Erik Vassella, Martin Zoche, Kirsten D Mertz

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Lab Links

A curated list of partners or recommended laboratories offering advanced molecular diagnostic services.

List under construction