Bacterial reverse mutation test (Ames) - Genotoxicity

The bacterial reverse mutation (Ames) test is used to evaluate the genotoxic effect of a medical device or its extract when in contact with a bacterial suspension. The test is conducted according to OECD 471 and ISO 10993-3 by exposing a bacterial suspension of Salmonella spp and Escherichia coli to 5 concentrations of the medical device or its extracts.

The Ames test is a preliminary "screening test" for genotoxicity. A full genotoxicity evaluation usually includes testing the device with two in vitro methods, of which Ames is one. An additional in vivo method can be used if needed.

Measurlabs can support you with the full genotoxicity evaluation. Please contact our experts for a quote.