MutaMouse at Labcorp: A 10-year historical review

UKEMS 2023 -- The OECD 488 test guideline (TG488) on Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays was first adopted in July 2011 and has been revised periodically in July 2013, June 2020 and most recently in June 2022. This guideline describes the use of a variety of transgenic rodent models to reliably measure gene mutations in vivo. A key requirement of OECD 488 guideline is for a laboratory to demonstrate competency and proficiency in the assay. At Labcorp, we have been performing this assay in the MutaMouse transgenic model for 25 years. Here we present a review of the last 10 years of performing the assay, along with our current tissue-specific historical control ranges in the more commonly requested tissues.