BioReliance Introduces Updated Big Blue Mouse Assay Service

Sigma-Aldrich Corporation’s BioReliance, the biologics and early-development services business under SAFC, has qualified the Big Blue Mouse Transgenic Rodent Mutation (TRM) assay to meet the new Organization for Economic Co-Operation and Development (OECD) Test Guideline 488 requirements for evaluation of in vivo mutagenicity.

Big Blue is identified in OECD Test Guideline 488, as well as recommended by various agencies and expert groups, including the European Chemicals Agency, as an accepted assay for evaluating mutagenicity in somatic and male germ cell tissues. BioReliance confirms that the Big Blue Mouse TRM assay service is immediately available.

BioReliance acquired the exclusive ownership of the Big Blue TRM assay and rodents from Agilent in March 2013. The assay service fulfills a specific need of pharmaceutical and chemical companies by providing a unique confirmatory test for drugs and chemicals that initially test positive in in vitro mutation assays. 

“We are pleased to offer this critical service to our clients,” stated Robert Young, study director for TRM assays at BioReliance. “Our company played a key role in the development and validation of the model in the early 1990s. We have now expanded our expertise by updating and qualifying the assay to meet the requirements of OECD 488, additional regulatory guidelines and the current needs of our clients. This new service complements BioReliance’s existing portfolio of comprehensive genotoxicity testing methods.”

BioReliance will present a scientific poster detailing the Big Blue TRM qualification studies at the upcoming EUROTOX Conference (1–4 September 2013, Interlaken, Switzerland). Big Blue TRM experts will be available for individual consultation at this event and at the Environmental Mutagenesis and Genomics Society Conference (21–25 September 2013, Monterey, Calif., US).