BioReliance, the biologics and early development services business of SAFC, has signed an agreement to acquire Agilent Technologies’ colonies for the Big Blue transgenic rodent mutation (TRM) assay and a license to its associated trademark.
TRM assays measure mutation frequency in any tissue and are the first in vivo genetic toxicology mutation assays to be approved by the Organization for Economic Co-Operation and Development (OECD). BioReliance now owns Big Blue mutation models and is the exclusive supplier of testing services based on this model.
BioReliance is completing the transfer of colonies and cell lines from Agilent and building full capacity and capability to perform the Big Blue assay. The company is in the process of re-qualifying the assay to meet new regulatory requirements and anticipates that Big Blue testing services will be commercially available in 2H13.
"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," said Daniel Aparicio, executive director and general manager of Early Development Services at BioReliance. "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."