Genotoxicity tests can be defined as in vitro and in vivo tests designed to detect compounds which induce genetic damage directly or indirectly by various mechanisms. The genotoxic substances induce damage to the genetic material in the cells through interactions with the DNA sequence and structure. This damage is generally considered to be essential for heritable effects and in the multi-step process of carcinogenicity.
A standard battery of genotoxicity studies is required by regulatory agencies prior to the authorization of phase I trials with a new drug. The analysis of all these results helps evaluate the potential risk of carcinogenicity due to DNA damaging mechanisms. The standard battery for genotoxicity includes the assessment of mutagenicity in a bacterial reverse gene mutation test (Ames test), since these assays have been shown to detect relevant genetic changes and the majority of genotoxic rodent and human carcinogens. Furthemore the Ames test is also used worldwide as an initial screen to determine the mutagenic potential of new chemicals and drugs.
Vivotecnia offers the following studies for the analysis of genotoxicity:
- Ames Test: Semi-automated Bacterial Reverse Mutation Test.
- COMET assay: DNA strand breakage assay also known as single cell gel electrophoresis assay is a sensitive and rapid test for quantifying and analysing DNA damage in individual cells.
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