Molecular Diagnostics Services, Inc.
A Contract Research Organization

In vitro Mammalian Gene Mutation Tests


The mammalian mutation assays measure forward mutations at two different loci. These loci control the expression of thymidine kinase (TK) or hypoxanthine- guanine phosphoribosyl transferase (HGPRT) or xanthine-guanine phosphoribosyl transferase (gpt). In order to evaluate the effect of metabolism on the test article, such tests are performed in the presence and absence of exogenous mammalian liver enzyme preparations (S9). The assays measure heritable genetic damage arising by several mechanisms in living cells and are capable of detecting chemicals that induce either gene mutations or heritable chromosomal events, including genetic events associated with carcinogenesis. This assay will be performed by either the soft agar or the microwell method.

These tests are offered in two different cell types and two different endpoints either the soft agar or the microwell methods. The assays measures heritable genetic damage arising by several mechanisms in living cells and are capable of detecting chemicals that induce either gene mutations or heritable chromosomal events, including genetic events associated with carcinogenesis. When such additional tests are performed because of the high level of toxicity of the test chemical to bacteria, it is still important to perform the bacterial reverse mutation test because some antibacterial agents, albeit highly toxic to the tester strains, are genotoxic at very low, sub-lethal concentrations in the bacterial reverse mutation test ( e.g., nitrofuran antibiotics).
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