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Genetic Diagnostics Act (GenDG)

The "Genetic Diagnostics Act" (GenDG) has been in force since February 1st, 2010

The Genetic Diagnostics Act (GenDG) has been in force since 1 February 2010. It regulates the handling of examinations of the characteristics of human DNA and genes, insofar as they were inherited before birth. However, it also applies to the examination of gene products if the aim of the examination is to gain knowledge about a genetic make-up.

This law applies to the epigenetic tests DNA adducts and SOD profile offered by the IGL laboratory. For all genetic diagnostic and especially for the epigenetic parameters and requirements, the physician's proviso applies. In addition, patient consent must be obtained.The consent form signed by the patient and doctor regulates:

  • Subject or scope of the examination
  • Consent to the taking of the sample and to the examination
  • Confirmation of the test result or destruction of the same and the decision on the whereabouts of the sample after analysis.

Before giving consent, the doctor must inform the patient about the nature, scope and consequences of the examination and document this information. In the case of persons incapable of giving consent (children, incapacitated), the legal representative signs.
If the declaration of consent is not provided, the analysis may not be carried out by the laboratory. It is not permissible to carry out the analysis and only withhold the result.
If there is no other instruction/consent from the patient, the sample must be discarded immediately after completion of the analysis. If the sample is still available due to an instruction given by the patient, subsequent requests for further genetic diagnostic tests may only be carried out if covered by the patient's written consent. Otherwise, a new consent is required.

The patient may withdraw from his/her declaration of consent at any time, also by telephone, but only vis-à-vis the responsible physician. This must then be documented accordingly. Results that have not yet been communicated must then be destroyed immediately. Results that have already been communicated, on the other hand, are not discarded but blocked.

The results of a genetic diagnostic test may only be communicated by the laboratory to the doctor who ordered the test, but not to the patient or to any other person. Disclosure to third parties (including other doctors) may only be made by the doctor responsible and only with the patient's written consent.
After 10 years, the results must be automatically destroyed, unless the patient requests that they be kept for longer or that they be blocked. Blocking has the effect of extending the retention period by 10 years from that time.

All examinations for which the patient's declaration of consent is required according to the GenDG are marked on the order form of the IGL laboratory.

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