In vitro mammalian cell mutation assays based on the Pig-a gene: A report of the 7th International Workshop on Genotoxicity Testing (IWGT) Workgroup.

Pig-a gene mutation assays enumerate cells with the glycosylphosphatidylinositol (GPI) anchor-deficient phenotype as a reporter of mutation in the endogenous Pig-a gene. Methods for measuring mutation in this gene are quite well established for in vivo systems. This approach to mutagenicity assessment has now been extended to in vitro mammalian cell-based systems. An expert workgroup from the 7th International Workshop on Genotoxicity Testing tasked with assessing the status of in vitro mammalian cell mutation assays has investigated the merits and limitations of in vitro Pig-a gene mutation assays. A review of the current status of these developing methodologies and the formation of consensus statements on the utility and application of these assays were performed to provide guidance for their potential use in genotoxicity hazard identification and risk assessment.