Midwest BioResearch Introduces Screen to Predicts the GLP Regulatory Ames Test
News Mar 20, 2007
Midwest BioResearch, LLC has announced the introduction of a microAmes screen that fully predicts the GLP regulatory Ames test (Salmonella/E. coli Mammalian Microsome Reverse Mutation Assay).
Evaluating compounds for mutagenic potential using the GLP regulatory Ames test is required for most small molecules prior to compound scale up and IND-enabling non-clinical studies.
Producing well-characterized test material of sufficient quantity to conduct a regulatory Ames test takes considerable investment both in chemical synthesis and in running a full plate GLP Ames test, activities which can take months to complete.
Using approximately 5-10 mg of chemist bench sample, MBR can screen for Ames mutagenicity in two weeks or less. By relying on experienced experts, MBR can generate an answer on Ames mutagencity during lead optimization.
Current screens for mutagencity use modified Ames bacterial tester strains, are run without a mammalian metabolic activation system, or are performed with just two of the five regulatory ICH-compliant tester strains often under conditions different than those of the regulatory Ames test. These other screens therefore do not measure all the endpoints needed to fully assess the mutagenic potential of a compound or chemical series or require much larger compound amounts.
MBR claims that microAmes uses all five Salmonella and E. coli tester strains recommended by regulatory agencies and evaluates colony formation, cytotoxicity and compound precipitation using an agar format, factors that make this screen the most predictive mutagenicity screen for the regulatory GLP Ames assay.
MBR also offers a micro-clastogenicity screen for predicting the regulatory GLP chromosomal aberration assay.
“We’ve raised the bar in genotoxicity screening by offering the industry’s first and only microAmes screen that fully predicts the GLP regulatory Ames test,” said Michael Schlosser, Ph.D., president and founder of MBR.
“Because we’ve had years of experience performing these types of genotoxicity screens within Big Pharma, we understand what clients are looking for and thus can better help them achieve their project milestones,” Schlosser continued.