NCTR Research Highlight - May 8, 2009

New Mechanistic Information for a Standard Genetic Toxicology Assay – Experiments confirm the full spectrum of adverse genetic mutations induced by chemical agents is detected by the Mouse Lymphoma Gene-Mutation Assay (MLA).  

NCTR scientists have recently completed research that capitalizes on newly developed molecular and cytogenetic techniques and provide definitive proof that the MLA is capable of detecting most, if not all, of the chromosomal mutations known to be involved in human-cancer development and other genetically based human disease.

The Mouse Lymphoma Gene-Mutation Assay is recommended in most international regulatory guidance, including the International Conference on Harmonization (ICH) and the Center for Food Safety and Applied Nutrition (CFSAN) Redbook as the in vitro gene-mutation assay for preclinical safety evaluation and for other regulatory decisions based on identifying the potential for a chemical to cause the induction of mutation and/or cancer.  The original recommendation for preferring this gene-mutation assay over a number of other in vitro gene-mutation assays was based on research elucidating the types of genetic damage detected by the assay.  Unfortunately, at the time this research was conducted, the findings were somewhat limited by the available technologies that could be applied to the analysis.  Recognizing the need for further clarification, NCTR scientists conducted the key research and published the results in the latest issue of Toxicological Sciences 109(1): 96-105, 2009.