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Telomere & Centromere FISH staining: reading genotoxicity mechanisms by high-content imaging
Cosmetic Pharma +3
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White paper
Interpretation of ambiguous results in genotoxicity
Ames (OECD 471) and in vitro micronucleus (OECD 487) tests: how we analyse equivocal results, decide on targeted investigations, use FISH to clarify the mechanism and reach a weight-of-evidence conclusion.
What's inside
- What an ambiguous (equivocal) result means in genotoxicity — and what it does not
- Our approach to the Ames test (OECD 471), with a worked example
- Our approach to the in vitro micronucleus test (OECD 487)
- Mechanistic analysis by FISH with centromeric probes: aneugenic or clastogenic?
- How we decide on additional investigations, and the three possible outcomes
- Weight-of-evidence interpretation and our five-step support process
An ambiguous result does not necessarily demonstrate a genotoxic effect. Conversely, it cannot be considered negative without scientific justification.
This white paper sets out how GenEvolutioN goes beyond a binary “positive / negative” reading: we first analyse the biological relevance of the observations, then, where necessary, propose targeted investigations to better characterise the signal.
Who this is for
- Toxicologists and safety assessors
- Regulatory affairs teams
- R&D and product safety managers commissioning genotoxicity studies
Recommended citation
GenEvolutioN Scientific Team (2026). Interpretation of ambiguous results in genotoxicity. GenEvolutioN Technologies.