High-Throughput Genotoxicity Testing

The registration of all pharmaceuticals requires a comprehensive safety assessment of their potential to cause direct or indirect genotoxic damage. This article reviews current methods employed for regulatory genotoxicity testing and new techniques developed for early high-throughput screening. A novel in vitro mammalian assay is described which detects all common mechanistic classes of genotoxins, and delivers both high specificity and sensitivity to address the urgent need for more accurate genotoxicity testing.