Genetic Toxicology

As you may know, Inotiv acquired the assets from BioReliance® Genetic Toxicology in July of 2021, and completed the acquisition of Integrated Laboratory Systems, LLC (“ILS”) services in January 2022. Inotiv’s Genetic Toxicology services now support your project with a full battery of validated genetic toxicology in vitro cell-based assays and in vivo assays to meet ICH, OECD, FDA, EPA, and international guidelines. We support standard and tailored services to meet your testing needs.

Our Genetic Toxicology team has worked with a broad spectrum of test articles and has performed thousands of genetic toxicology studies in accordance with international guidelines. Studies are conducted in full compliance with GLP regulations, or to non-GLP where needed. As your partner, you now have access to a team with years of experience in:

To assess your test article’s potential to induce gene mutations or cause chromosomal damage, Inotiv offers in vitro and in vivo solutions that include the following battery of tests:

Bacterial reverse mutation assay (Ames assay)

In vitro micronucleus assay

In vitro chromosomal aberration assay

In vivo micronucleus assay (rodents)

In vivo comet assay (rodents)

Combined in vivo micronucleus/comet assay (rodents)

Follow up assays including the in vivo Pig-a gene mutation assay

Inotiv provides insights through a cost-effective, non-GLP genetic toxicology screening program that is designed to quickly determine the genotoxic potential of your substance. Our approaches include:

Mini Ames assay

Microwell and mini in vitro micronucleus assay

In vitro high content MultiFlowⓇ assay for mode of action predictions

In vivo Micronucleus and Comet

Inotiv offers Quantitative Structure–Activity Relationship (QSAR) as an in silico method for predicting chemical substances causing adverse effects based on their chemical structures. Our expert rule and statistical-based models include:

LeadscopeⓇ

CASE Ultra

Derek/Sarah NexusⓇ OECD

OECD QSAR Toolbox

To learn more about how we can help move your program forward, please contact us to discuss your needs.

Drug Metabolism and Pharmacokinetics (DMPK) Drug Metabolism and Pharmacokinetics (DMPK) Whatever you need, from method development to metabolite ID, our phase-appropriate bioanalytical services help you analyze, answer, and advance.

Histology Histology Our industry-leading histology laboratories support your discovery and nonclinical development projects with a wide range of services. From tissue processing to digital analysis, our team delivers the quality you expect.

Pathology Pathology Access world-class anatomical, clinical, and medical device pathology services, from routine histochemistry, IHC, IF, and ISH to stereology.

In Vivo Services In Vivo Services From discovery to regulatory-enabling safety assessments in advanced developmental and reproductive toxicology (DART), we have the in vivo services and associated bioanalysis capabilities you need to find answers.

Consulting Consulting Our experts deliver the insights you deserve to get the answers you need, whether in DMPK data analysis, biomarker analysis, or bioequivalence studies.