Genotoxicity Services

Vivotecnia’s genotoxicity services help you assess your product’s potential to induce genetic mutations or chromosomal damage which is generally considered essential to produce inheritable effects or to mediate the different stages of tumor formation. Genotoxicity tests are designed to detect compounds that directly or indirectly cause these types of genetic damage by different mechanisms.

Regulatory agencies require a standard battery of genotoxicity studies prior to authorization to conduct Phase I clinical trials with a new drug. Analysis of combined study results helps to assess the compound’s potential risk of genotoxicity due to DNA damage mechanisms. The standard battery for determining genotoxicity includes the assessment of mutagenic damage in a bacterial reverse gene mutation assay (Ames test), as these assays have been shown to detect relevant genetic changes as well as most genotoxic carcinogens for rodents and humans. In addition, the Ames test is used worldwide for an initial screening to determine the mutagenic potential of new chemicals or drugs.

Vivotecnia offers the following genotoxicity services to evaluate your product’s genotoxicity:

• Ames test: semi-automated bacterial reverse mutation test
• Comet assay: single cell gel electrophoresis to sensitively and rapidly quantify damage to cellular DNA
• Mini-Ames test: scaled-down version of the Salmonella reverse mutation test (Ames test, OECD 471) for initial screening