Mutational profiling in human cells as an in vitro alternative to in vivo mutagenicity assessments

项目摘要 突变是细胞基因组中可遗传的变化，是诱发癌症、出生和死亡的关键事件。 缺陷和神经系统疾病。缺乏人体细胞中的致突变性生物测定是研究中的一个主要数据缺口。 监管机构用于危害识别和定量风险的遗传毒理学测试组合 评估。ScitoVation正在开发一种结合人类细胞和 纠错的下一代测序作为当前调节性哺乳动物细胞的体外替代方法 使用啮齿动物细胞系进行致突变性评估，并作为体内突变试验的体外替代方法。

PROJECT SUMMARY Mutations are heritable changes in the cellular genome and are key events in the induction of cancer, birth defects, and neurological diseases. The lack of a mutagenicity bioassay in human cells is a major data gap in the genetic toxicology test battery used by regulatory agencies for hazard identification and quantitative risk assessments. ScitoVation is developing a New Approach Methodologies (NAMs) combining human cells and Error Corrected Next Generation Sequencing as an in vitro alternative to current regulatory mammalian cell mutagenicity assessment using rodent cell lines, and as an in vitro alternative to in vivo mutation assays.