Preclinical Genotoxicity Testing Services (Genetic Toxicity)

Genotoxicity studies are done to determine the mutagenic potential of various products prior to widespread use in humans. Since DNA-reactive substances may initiate a carcinogenic process, screening strategies with built-in mode of action information are becoming more useful for biologically assessing potential human risk. The operable mechanisms (i.e., biological key events) can then be evaluated in the context of an adverse outcome pathway to identify a probable molecular initiating event that is responsible for the positive test results. While genotoxicity testing is required for all classes of chemicals and drugs, the testing strategy should be tailored to the applicable regulatory requirements and responses observed in vitro.