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Transferability and Reproducibility of the HepaRG CometChip Assay
Leslie Recio1,2, Carol Swartz1,3, Lincoln Martin1,3
1Integrated Laboratory Systems, Research Triangle Park, North Carolina, USA.
Environmental and Molecular Mutagenesis
|November 26, 2025
Summary
The HepaRG CometChip assay demonstrated good transferability and reproducibility across four laboratories for genotoxicity testing. This new approach methodology (NAM) shows promise for replacing animal testing strategies.
Area of Science:
- Toxicology
- Genotoxicity Testing
- In Vitro Assays
Background:
- New Approach Methodologies (NAMs) are crucial for reducing animal testing.
- The HepaRG CometChip assay is a novel in vitro method for genotoxicity assessment.
- Interlaboratory evaluations are essential for validating NAM transferability.
Purpose of the Study:
- To evaluate the transferability and reproducibility of the HepaRG CometChip assay across multiple laboratories.
- To assess the performance of the HepaRG CometChip assay for genotoxicity testing of various chemicals.
- To determine the suitability of the HepaRG CometChip assay as a rodent replacement strategy.
Main Methods:
- Four laboratories participated in an interlaboratory evaluation of the HepaRG CometChip assay.
- Cytotoxicity was assessed using ATP quantification.
- Genotoxicity was evaluated by comet analysis, measuring %Tail DNA.
- Positive response defined by statistically significant, concentration-related increases in %Tail DNA.
Main Results:
- Unanimous agreement on test results for 8 out of 11 compounds across all four labs.
- High agreement (3 out of 4 labs) for the remaining chemicals.
- The assay showed good reproducibility, with majority agreement for all compounds.
- Low %Tail DNA for bulky adducts due to inherent alkaline comet assay limitations.
Conclusions:
- The HepaRG CometChip assay is transferable and reproducible across laboratories.
- This platform is a promising human-relevant NAM for genotoxicity testing.
- The assay's physiologically relevant detoxification process supports its use in rodent replacement strategies.
