The Big Blue Mouse Transgenic Rodent Mutation (TRM) assay has been recommended for the assessment of potential mutagenicity of biopharmaceutical compounds by the Organization for Economic Co-Operation and Development (OECD) for many years as part of test guideline 488.
The OECD - a multicountry organisation intended to promote economic development - adopted the latest version of 488 in July 2013 just months after Bioreliance acquired exclusive rights to the Big Blue Mouse assay from Agilent, which prompted the SAFC unit to reassess the test.
As a result Biorelaiance relaunched an updated version of the technology that had been re-evaluated according to guideline 488 last September.
The new version of the assay released this week “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 with either mice or rat models."
According to a spokeswoman for Bioreliance the new assay "can be used in rats [and is] only one on the market with that option."
DNA resolution
The ability to test for damage at the DNA levels is unique to the Big Blue assay according to Scott Hickman, marketing Manager for Bioreliance’s toxicology testing business who spoke with BioPharma-Reporter.com in September.
Hickman told us that: “Big Blue is designed as a follow up assay that can be applied to any type of pharmaceutical, industrial consumer chemical, or cosmetic, which appears to have mutagenic properties. In other words, the method can be applied to any product that has the capability of causing DNA damage in humans.”
He added that: “It is important to note that Big Blue is a tier 2 assay. This type of assay is typically utilized after the tier 1 assays have been completed. Tier 1 assays also test for a compound’s ability to cause genetic damage, but are mostly carried out as in vitro studies.
“Big Blue is the only transgenic rodent mutation (TRM) assay that can go deeper and test for mutagenicity (mutations such as cancer) at the DNA level, as well as determining the types of DNA damage caused.”