Genotoxicity

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.

Cyprotex offer a range of screening (non-GLP) services to identify genotoxicity.

Screening methods are performed under non-GLP conditions and include the 2 strain Ames test, in vitro MNT (CHO-K1) or in vitro MNT (TK6), the γH2AX double strand DNA damage assay and the combined pH3 and pH2AX assay for differentiating between aneugens and clastogens.

• Ames test - Screening
• In vitro micronucleus test (HCS; CHO-K1 cells)
• In vitro micronucleus test (flow cytometry; TK6 cells)
• γH2AX double strand DNA damage
• pH3 and pH2AX genotoxicity assay
• Custom toxicology