Bemis J C, Heflich R H
Litron Laboratories, Rochester, NY, USA.
US Food and Drug Administration, National Center for Toxicological Research, Jefferson, AR, USA.
Mutat Res Genet Toxicol Environ Mutagen. 2019 Nov;847:403028. doi: 10.1016/j.mrgentox.2019.03.001. Epub 2019 Mar 7.
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.
Pig-a基因突变试验将具有糖基磷脂酰肌醇（GPI）锚定缺陷表型的细胞计数作为内源性Pig-a基因突变的报告指标。在体内系统中，测量该基因突变的方法已经相当成熟。这种致突变性评估方法现已扩展到基于体外哺乳动物细胞的系统。第七届遗传毒性测试国际研讨会的一个专家工作组负责评估体外哺乳动物细胞突变试验的现状，该工作组研究了体外Pig-a基因突变试验的优点和局限性。对这些正在发展的方法的现状进行了综述，并就这些试验的实用性和应用形成了共识声明，以为其在遗传毒性危害识别和风险评估中的潜在应用提供指导。
