Genotoxicity

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. 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.

Genotoxicity Studies

Vivotecnia offers a battery of studies for the analysis of genotoxicity according to ICH guideline S2B:

• Ames Test: Bacterial Reverse Mutation Tests
• Micronucleus Test: Test of Mammalian Erythrocyte Micronucleus
• Mouse Lymphoma Assay:  In vitro Gene Mutation Assay using mammalian cells