Genetic Toxicology Studies

Genetic Toxicology Testing

Genetic toxicology (genetox) studies are conducted to assess the mutagenic potential of various products prior to widespread use in humans. Since DNA-reactive substances may initiate the carcinogenic process, screening strategies with built-in mode of action information are becoming more useful for biologically assessing potential human risk. The operable mechanisms (i.e., biological key events) can then be evaluated in the context of an adverse outcome pathway to identify a probable molecular initiating event responsible for the positive test results. While genetic toxicology testing is required for all classes of chemicals and drugs, the testing strategy should be tailored to the applicable regulatory requirements and responses observed in vitro. While most studies are performed in vitro, we also incorporate in vivo genetic toxicology studies, when necessary.

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Genotoxicity Assays for Genetic Toxicology Studies

The basic genetic toxicology test battery is a standard set of assays used to assess the mutagenic potential of a substance. It typically includes in vitro tests like the Ames test and an in vitro mammalian cell assay, and an in vivo test like the micronucleus assay. The specific tests required will depend on the nature of the product and regulatory guidelines.

In Vivo GLP Assays

• Rodent Micronucleus Test (OECD 474)
• Bone Marrow Chromosome Aberration (OECD 475)
• Mammalian Alkaline Comet Assay (OECD 489)
• Combined Comet/Micronucleus Assay
• Pig-a Gene Mutation Assay

In Vitro GLP Assays

• Bacterial Mutation Test (Ames, OECD 471)
• Mammalian Cell Micronucleus Assay (OECD 487)
• Mammalian Chromosome Aberration Test (OECD 473)
• Mammalian Cell Gene Mutation Test (TK Gene (MLA), OECD 490)
• Mammalian Cell Gene Mutation Test (HPRT Gene, OECD 476)
• 3D skin comet assay

Screening Assays

• Micro Ames, Ames MPF, Ames II, mini Ames
• Mammalian Cell Micronucleus Assay screening
• Multiflow Assay
• 3D liver-on-chip combined with comet assay

In Vitro Follow-up Mode of Action Evaluation

• Multiflow Assay
• Fluorescence In Situ Hybridization (FISH)

Other

• Medical Devices testing

Our Genetic toxicology team collaborates closely with other Safety Assessment experts to provide comprehensive support. We excel at designing custom studies for unusual projects and problems. Our scientists have tested By combining genetic toxicology expertise with services like formulation, analytical chemistry, pathology, and bioanalysis, we deliver robust and reliable study results. To gain deeper insights, we employ advanced techniques such as in situ hybridization and flow cytometry to identify genetic toxicology biomarkers and elucidate mechanisms of action.

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Mitigate Genetic Toxicity Risks for Regulatory Success

With over 30 years of experience, we are a trusted partner in genetic toxicology for testing pharmaceuticals, chemicals, agrochemicals, and other impurities. Our global team of scientists and regulatory experts provides tailored testing strategies and conducts a comprehensive suite of assays to meet the unique needs of your product. Our deep engagement with regulatory bodies like the OECD and industry groups like the HESI-GTTC ensures you benefit from the latest scientific advancements and regulatory insights. Our company has been providing a full battery of validated genetic toxicology cell-based and in vivo assays, for decades, that meet ICH, OECD, FDA, EPA, EFSA and other international guidelines.

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Frequently Asked Questions (FAQs) About Genetic Toxicology Studies