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Advances in our understanding of the mechanisms of carcinogenesis combined with the ability to create transgenic animals have given toxicologists new tools with which to test materials for potential carcinogenic activity. Our understanding of how oncogenes are activated and tumor suppressor genes inactivated together with the technology with inserting such altered genes into the murine genome, has permitted the construction of specific transgenic constructs designed to investigate mechanisms of carcinogenicity.

The Food and Drug Administration (FDA) announced in 1997 that it adhere to the International Conference on Harmonization (ICH) S1B Guideline "Testing for Carcinogenicity of Pharmaceuticals."¹ This was a dramatic milestone for institutionalizing the use of short-term transgenic mouse models for carcinogenicity testing. Much of the early validation wok that led to the FDA acceptance of the ICH guideline was carried out at BioReliance under a National Toxicology Program (NTP) contract, giving BioReliance a unique advantage in this new area of toxicology. BioReliance also participated in the research collaboration organized by the International Life Sciences Institute (ILSI). These new alternative animal models are now accepted globally by regulatory agencies as a replacement for one of the two long-term lifetime studies that were previously required, and give results in less than one year.

Short term transgenic studies bring you an accelerated time-to-market and the security and confidence you need now with the approval of the regulatory authorities.

Since BioReliance was involved in the validation of the ICH accepted models, we are uniquely positioned to assist the pharmaceutical and industrial chemical industries based on our unrivaled hands-on experience with these models. The validation work has allowed us to create the largest historical control tumor database of these strains in the industry. This gives our transgenic studies considerable power and added confidence when interpreting rare tumors.

Clients can be confident that BioReliance's transgenic carcinogenicity studies meet the highest industry standards, combining superior hands-on experience with state-of-the-art technologies.


To find out more about BioReliance transgenic carcinogenicity studies, download our four-page transgenic carcinogenicity brochure.

1- ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), Guidelines S1B "Testing for Carcinogenicity in Pharmaceuticals." http://www.ich.org

Assays offered by BioReliance: