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

> **NIH NIH R44** · SCITOVATION, LLC · 2024 · $910,332

## Abstract

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.

## Key facts

- **NIH application ID:** 10845665
- **Project number:** 5R44ES035336-02
- **Recipient organization:** SCITOVATION, LLC
- **Principal Investigator:** LESLIE RECIO
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $910,332
- **Award type:** 5
- **Project period:** 2023-05-23 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10845665

## Citation

> US National Institutes of Health, RePORTER application 10845665, Mutational profiling in human cells as an in vitro alternative to in vivo mutagenicity assessments (5R44ES035336-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10845665. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*