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MUTATIONAL PROFILING IN HUMAN CELLS AS AN IN VITRO ALTERNATIVE TO IN VIVO MUTAGENICITY ASSESSMENTS

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Principal Investigator: Recio, Leslie
Institute Receiving Award Scitovation, Llc
Location Durham, NC
Grant Number R44ES035336
Funding Organization National Institute of Environmental Health Sciences
Award Funding Period 23 May 2023 to 30 Apr 2025
DESCRIPTION (provided by applicant): 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.
Science Code(s)/Area of Science(s) Primary: 09 - Genome Integrity
Secondary: 03 - Carcinogenesis/Cell Transformation
Publications No publications associated with this grant
Program Officer Daniel Shaughnessy
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