Regulatory excellence meets next-gen science
The field of genotoxicity testing has evolved dramatically over the past decade, with international guidelines—primarily from the OECD, ICH, ISO, EMA, and FDA—setting the gold standard for regulatory compliance. But as science advances, so do the expectations for speed, precision, and ethical standards. Today, companies must not only meet rigorous requirements, but also anticipate the next wave of innovation that is reshaping how we assess genotoxic risk.
OECD, ICH, ISO, EMA, FDA: the foundations of genotoxicity testing
The Organisation for Economic Co-operation and Development (OECD) provides the globally recognized guidelines for genotoxicity assays, from the Ames test (OECD 471) to in vitro micronucleus assays (OECD 487).The ICH guidelines on Safety are designed to standardize the toxicological evaluation of pharmaceuticals across major regulatory agencies (e.g., FDA, EMA, PMDA), ensuring scientific rigor and reducing redundancy in animal testing.
Regulatory bodies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) further specify requirements, ensuring that pharmaceutical and cosmeticproducts are thoroughly evaluated for DNA-damaging potential before reaching the market. In addition, ISO 10993, an international standard titled “Biological evaluation of medical devices”, published by the ISO (International Organization for Standardization) provides a framework for assessing the biocompatibility of medical devices prior to their clinical use or market release.
These guidelines ensure:
- Data integrity and reproducibility
- Global harmonization
- Animal welfare considerations (promoting alternatives to in vivo tests)
However, compliance is only the starting point. In today’s landscape, the real differentiator is the ability to innovate within the regulatory framework.
Innovation in practice: miniaturization, customization, and human-relevant models
At GenEvolutioN, we’re not just following the rules—we’re helping to write the next chapter. Our lab implements cutting-edge solutions to address both the regulatory mandates and the industry’s demand for faster, more reliable, and more ethical testing.
What sets us apart?
- 2D/3D Human Cell Models: Reconstructed human epidermis, cornea, and skin organoids that mirror in vivo biology more closely than ever.
- Advanced Imaging a: High-content imaging with innovative staining such as FISH staining for telomere & centromere
- Molecular method: Early detection of genotoxic events with mechanistic insights into modes of action
- Advanced analytical chromatography platform with mass spectrometry for icharacterization
- Miniaturized, High-Throughput Assays: 25-well AMES Miniscreen, 384-well AMES MPF, 24-well MicroNucleus and more—saving time, sample volume, and costs.
- Custom Protocols: Tailored early-stage risk assessment to de-risk R&D pipelines and accelerate time-to-market.
Looking ahead: the future of genotoxicity assessment
The future is clear: alternatives to animal testing and next-gen in vitro models are becoming the new regulatory norm. GenEvolutioN is already paving the way, with validated methods that align with global standards while continuously pushing the boundaries of what’s possible.
We actively participate in scientific consortia and collaborate with regulatory agencies to ensure that our clients benefit from the latest breakthroughs—whether it’s faster risk identification, more accurate data, or smoother regulatory submissions.
Why choose GenEvolutioN?
Because we combine:
- Regulatory mastery (OECD, ICH, EMA, FDA compliance)
- Technical innovation (2D/3D models, advanced analytics)
- Agility and speed (miniaturized formats, custom protocols)
- A future-focused mindset (alternatives to animal testing, ongoing validation)
Partnering with GenEvolutioN means turning regulatory complexity into a competitive advantage—today and tomorrow.
Ready to take your genotoxicity testing to the next level?
Contact our team or discover more at www.genevolution.fr
