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26 Mar 2014

BioRelianc?e Expands Commercial Capabiliti?es of Big Blue Assay

BioReliance, Sigma-Aldrich Corporation’s biologics and early-development services business under SAFC Commercial (, has expanded commercial availability of its exclusive Big Blue Transgenic Rodent Mutation (TRM) assay to identify and measure mutations in somatic tissue and germ cells. The assay enables follow-up testing of pharmaceutical and chemical products that have shown positive results in genotoxicity or carcinogenicity assays and can be used to investigate possible mutagenic modes of action. This test is now available for use with either mouse or rat subjects.


Big Blue TRM is the only assay of its kind on the market that

• Has been validated for application to measure mutations in both mice and rats, allowing the investigation of earlier results in both species

• Was developed through support from the National Institute of Environmental Health Sciences’ National Toxicology Program (NTP)

• Features mouse and rat strains designed to be identical to mouse and rat strains used in NTP carcinogenicity studies

• Is under the ownership and guidance of an original developer of the assay

• Features complete control of animal colonies to ensure animal availability

• Works with inbred homozygous mouse and rat lines to permit cross-breeding with other transgenic lines to investigate mutagenicity associated with disease conditions

• Offers comprehensive assay support and access to the expertise of BioReliance scientists.


Other differentiating factors of the Big Blue assay include

• Qualification to meet Organisation for Economic Co-operation and Development Test Guideline 488 requirements for evaluation of in vivo somatic cell and germ cell mutagenicity

• Endorsement by the International Working Group for Genetic Toxicology (IWGT)

• Recommendation by the European Chemicals Agency and referenced in ICH, FDA, EMEA, and EFSA Guidelines

• Robust mutant frequency detection (p<.00001)

• 3R alignment – previous in vivo mutation options used hundreds of animals compared to study sizes of 25

• The ability to investigate mutagenic mode of action after genotoxic positives in almost any tissue of the body.


BioReliance is making multiple presentations on the assay at this week’s Society of Toxicology’s 53rd Annual Meeting and Tox Expo, through the 27th in Phoenix, as follows:

• Tuesday, 25 March at 11:00 a.m. in Room 106C West: “Big Blue Transgenic Rodent Mutation Assay and Novel Renal Proximal Tubule Epithelial Cell Line (RPTECs) – Fulfillment of an Unmet Need in Genetic Toxicology and Nephrotoxicity.”

• Wednesday, 26 March, at 1:00 pm in Exhibit Hall:  “Somatic and Germ Cell Mutant Analysis in the Big Blue Transgenic Mouse Mutation Assay with N-Ethyl-N-nitrosourea (ENU)”.  Poster number 362

• Wednesday, 26 March, at 1:00 pm in Exhibit Hall:  “Integration of Pig-a and Micronucleus Endpoints into the Big Blue Transgenic Mouse Mutation Assay:  Results for Benzo(a)pyrene (BaP) and N-Ethyl-N-nitrosourea (ENU)”. Poster number 363

For more information on the Big Blue Mouse and Rat TRM assay service, click here.

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