Medicilon offers a variety of in vitro and in vivo genotoxicity testing including those constituting the regulated battery of assays designed to detect physical and chemical agents that induce genetic damage by various mechanisms and are used for the registration of pharmaceuticals for human use and risk assessment from exposure to mutagenic and potential carcinogenic agents. In addition, Medicilon offers rapid screening assays that are cost-effective in assessing genotoxicity of products specifically during drug discovery and development stage. Medicilon also provides in vitro cytotoxicity testing services to pharmaceutical, cosmetic and medical devices industries to screen products for bioreactivity, cell viability and cell growth inhibition.
A genotoxicity testing is designed to detect compounds that cause genetic damage either directly or indirectly in cells exposed to the toxic substrates. Genotoxicity studies may be performed in vitro or in vivo.
Compounds which are positive in tests that detect such damage have the potential to cause cancer and/or heritable defects. No single test is capable of detecting all relevant genotoxic agents; therefore, the usual approach is to carry out a battery of tests that are complementary rather than representing different levels of hierarchy. With over 25% of compounds width a genotoxic liability reaching preclinical development, there is an urgent need for more accurate genotoxicity testing; a novel assay fulfills this need by combining high sensitivity with an extremely low false positive rate – enabling the all-important non-genotoxic compounds to become the focus of drug discovery research.
The purpose of genotoxicity testing is to determine if a substrate will influence genetic material or may cause cancer. They can be performed in bacterial, yeast, and mammalian cells. With the knowledge from the tests, one can control early development of vulnerable organisms to genotoxic substances.
Approval and registration of drugs requires a comprehensive assessment of their genotoxic potential. Genotoxicity testing is an integral component of regulatory toxicity evaluation in most countries. Since no single test is capable of detecting all relevant genotoxic end-points, a battery of in vitro and in vivo tests for genotoxicity is recommended by regulatory agencies. The recommended standard test battery includes in vitro tests for gene mutation in bacteria (Ames test) and in mammalian cells (mouse lymphoma assay) or an in vitro test for chromosomal damage in mammalian cells (in vitro micronucleus test or in vitro metaphase chromosomal aberration assay). Eventually, an in vivo test for chromosomal damage (in vivo micronucleus or in vivo chromosomal aberration assay) is required by regulatory agencies as part of an IND application.
In the recent years, assessment of genotoxicity testing has evolved towards earlier stages of drug discovery in order to identify genotoxic liabilities as soon as possible. Assays such as the Ames fluctuation test and the in vitro micronucleus assay (for the assessment of the in vitro chromosomal aberration) are routinely used for screening drug discovery compounds.
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