BioReliance signed an agreement to acquire the colonies required for the Big Blue® transgenic rodent (mice) mutation (TRM) assay and to obtain a license to its associated trademark from Agilent Technologies. TRM assays, which measure mutation frequency in any tissue, are the first in vivo genetic toxicology mutation assays to be approved by the Organization for Economic Co-Operation and Development (OECD), meeting Testing Guideline 488, according to BioReliance.
BioReliance is now the owner of Big Blue mutation models and the exclusive supplier of testing services based on this model, said Daniel Aparicio, executive director and general manager of early development devices at BioReliance.
“It is often of critical importance to use an in vivo mutation assay in order to assess human risk in drug development and chemical manufacturing. Big Blue is such an assay and one we are intimately familiar with, having been part of the initial co-development team in the 1990s,” continued Aparicio. “Based on feedback from our customers and from the market in general, we believe there will be an ever-increasing demand for transgenic rodent assays and we are delighted to be able to bring that capability to customers on the back of this agreement.”
BioReliance is now focused on completing the transfer of colonies and cell lines from Agilent and building full capacity and capability to perform the Big Blue assay, according to Aparicio. BioReliance is in the process of requalifying the assay to meet new regulatory requirements and anticipates that Big Blue testing services will be commercially available in the second half of the year.