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.