Genotoxic chemicals exert their adverse effect through interaction with genetic material (DNA) of cells. Genotoxicity tests are designed to detect drugs which can induce genetic damage directly or indirectly by various mechanisms of action. Compounds identified as genotoxic in these tests have the potential to be human carcinogens and/or mutagens, and ultimately may induce cancer and/or heritable defects.
Genotoxicity testing of new chemical entities is an integral part of the drug development process and is a regulatory requirement prior to the approval of new drugs. By identifying genotoxicity at an early stage in drug discovery rather than during regulatory assessment, the likelihood of late stage failures is reduced.