Evaluation of potential genetic toxicity is an important safety consideration that takes place during the development of a drug or medical device. Genetic toxicity studies assess the potential that the drug or medical device may cause changes or damage to DNA and/or chromosomes.
Interpreting genetic toxicity test results during product development takes experience and a fundamental understanding of the various biological mechanisms of action that may be involved. Regardless of hazard type, the experts at iuvo BioScience will help you understand the impact of test results on your specific product’s development, and will suggest testing strategies to hasten regulatory submission. With iuvo BioScience you can have confidence that we have the scientific experience and Regulatory knowhow to successfully design, interpret and manage your genotoxicity test results.
iuvo BioScience also offers the integration of peripheral blood micronucleus and Pig-a evaluations into repeat dose rodent toxicity studies. This approach not only is both cost effective and time efficient, it is also 3R’s friendly by reducing the total number of animals required for risk assessment. In addition, the assays marked below with an asterisk (*) will be professionally scored by Litron Laboratories, a leader in the field of genetic toxicology and developer of state-of-the-art methods for detecting genotoxicity using flow cytometry. Together, iuvo and Litron partner to bring the highest level of expertise to your genetic toxicity testing.
Ames bacterial reverse mutation assay, OECD 471
In vitro chromosomal aberration assay, OECD 473
In vivo mammalian alkaline comet assay, OECD 489
Mammalian forward gene mutation assay (TK locus, MLA), OECD 490
Rat Pig-a gene mutation assay*, ICH M7
Rodent bone marrow cytogenetic analysis (chromosomal aberrations), OECD 475
Rodent erythrocyte micronucleus assay (peripheral blood*/ bone marrow), OECD 474