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:
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Vivotecnia has designed a complete and robust bacterial reverse mutation test, called AMESplus1
Mini Ames Test
Vivotecnia offers mini AMES test as a pre-screening `miniaturized`version of the standard Salmonella reverse mutation assay (Ames test, OEDC 471)