Genotoxicity Assay Scores Top Marks in New Pharmaceutical Study

Gentronix showcased its latest product and service developments at the Society of Toxicology 49th Annual Meeting and ToxExpo Salt Lake City. New research using 75 marketed pharmaceuticals shows GreenScreen HC from Gentronix is more predictive for genotoxic carcinogenicity than existing regulatory in vitro assays. Published in Mutagenesis, the analysis provides additional evidence to support the use of the Gentronix assay in
the early identification of genotoxic liability or in non-clinical safety assessment of candidate pharmaceuticals during development. As well as more accurate prediction of in vivo genotoxicity (88%) and genotoxic carcinogenicity (93%) than other in vitro genotoxicity tests, the assay maintained its high specificity: no new genotoxicity and/or carcinogenicity alerts were produced for any of the compounds tested.

All marketed pharmaceuticals have other published regulatory in vitro and in vivo genotoxicity data, and often carcinogenicity study data. These allow accurate calculation of predictive statistical data. The accumulated data from carcinogenicity and regulatory genotoxicity studies to date, including this new study, shows the overall specificity and sensitivity of GreenScreen HC for genotoxic carcinogenicity to be 95% and 87.5% respectively. Data from this human cell-based assay has application in ‘weight of evidence’ approaches when assessing the biological relevance of positive in vitro mammalian cell assay data, where no bacterial mutagenicity has been observed, prior to conducting in vivo testing. With the high throughput, low resource and compound requirement of GreenScreen HC, data can be generated at an earlier stage of the drug development process. This additionally allows prioritisation of compounds to be progressed for non-clinical studies to support clinical investigations.