# Next Generation Testing Strategies for Assessment of Genotoxicity

> **NIH NIH R44** · LITRON LABORATORIES, LTD. · 2020 · $474,671

## Abstract

Project Summary
 It is well recognized that current batteries of genetic toxicology assays exhibit two critical deficiencies.
First, the throughput capacity of in vitro mammalian cell genotoxicity tests is low, and does not meet current
needs. Second, conventional assays provide simplistic binary calls, genotoxic or non-genotoxic. In this scheme
there is little or no consideration for potency, and virtually no information is provided about molecular targets
and mechanisms. These deficiencies in hazard characterization prevent genotoxicity data from optimally
contributing to modern risk assessments, where this information is essential. We will address these major
problems with current in vitro mammalian cell genetic toxicity assays by developing methods and associated
commercial assay kits that dramatically enhance throughput capacity, and delineate genotoxicants' primary
molecular targets, while simultaneously providing information about potency. Once biomarkers and a family of
multiplexed assays have been developed for these purposes, an interlaboratory trial will be performed with
prototype assay kits to assess the transferability of the methods.

## Key facts

- **NIH application ID:** 9838229
- **Project number:** 5R44ES029014-03
- **Recipient organization:** LITRON LABORATORIES, LTD.
- **Principal Investigator:** Jeffrey C Bemis
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $474,671
- **Award type:** 5
- **Project period:** 2018-03-01 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9838229

## Citation

> US National Institutes of Health, RePORTER application 9838229, Next Generation Testing Strategies for Assessment of Genotoxicity (5R44ES029014-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9838229. Licensed CC0.

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