Inotiv provides all genetic toxicology tests
needed for global regulatory compliance
A standard (harmonized) battery of genetic toxicology assays is an integral part of many global regulatory guidelines. Ensure compliance with Inotiv's comprehensive genetic toxicology testing services. We understand the nuances of guidelines across different regions (US, EU, Japan) and product types (pharmaceuticals, agricultural chemicals, etc.). Our extensive portfolio of genetic toxicology assays and adaptable study designs are tailored to meet your specific needs.
Our standard GLP genetic toxicology battery provides a critical first step in assessing the safety of your product. This initial testing phase routinely includes assays designed to detect gene mutations (alterations in DNA sequence) and cytogenetic damage (abnormalities in chromosome structure or number).
Should the initial GLP studies indicate potential genetic toxicity, subsequent follow-up genetox assays are essential for further evaluation. These follow-up studies can be performed in vitro, or more typically, in vivo studies are often the next step. These in vivo genetox assays provide crucial information about how the substance behaves within a biological system and its potential to cause genetic damage in a more complex setting.
| Mutation | Cytogenetic Damage | DNA Damage |
|---|---|---|
| Ames assay | In Vitro Micronucleus assay | Comet assay |
| HPRT assay | Chromosome Aberration assay | |
| Mouse Lymphoma assay | In Vivo Micronucleus assay | |
| Pig-a assay |
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