In the last ten years, a high amount of genetic assays has been developed for molecular biopathology and
genetic laboratories of the hospitals, mainly developed and provided by external companies. In some cases, the specialized
staff members of the hospitals (doctors, biopathologists, geneticists or pharmacists) develop their own methods. The
validation of these methods is required before their use in clinical testing, in order to assess its reliability. Analytical
methods are validated under the requirements of International Guidelines, but validation procedures for clinical genetic
tests are under study and need clarifications. In this manuscript, the main information related to the field of genetic
validation is revised, including statistics, explaining the difficulty of validation for some of the developed genetic tests.
The provided information is in agreement with all the International Guides. The information could be useful by the
workers daily performing this kind of analysis.