Genotoxicity is based on the ability of chemicals to damage genetic information within a cell. A wide variety of assays for genotoxicity are being developed and many mutagens and their associations with cancer-causing substances are described. The science of genetic toxicology deals with cancer-causing substances and mutagenic systems underlying hereditary effects. Many types of cancer are a multistage genetic disease that requires mutation.
Genotoxicity tests assess gene mutations, changes in chromosome or DNA, and gene toxicities caused by byproducts or compounds over an extended period of time. The ISO 10993-3 standard, published by the International Standards Organization (ISO), provides test methods for genotoxicity, carcinogenicity, and reproductive toxicity. The full name of this standard is: ISO/CD 10993-3 Biological evaluation of medical devices - Part 3: Testing for genotoxicity, carcinogenicity and reproductive and developmental toxicity (this standard is still under development).
ISO criteria for genotoxicity testing; requires the following considerations:
The US Food and Drug Administration (FDA) also recommends the following three genotoxicity tests:
In the test, analysis, measurement and evaluation studies carried out in our organization, national and international standards and applicable legal regulations are complied with and reliable and impartial results are obtained. Among the numerous tests carried out in this context, there are also genotoxicity testing services.
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