ICH S2(R1) Guideline

In Vitro Micronucleus Testing

The "Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use", was signed on November 9, 2011.

Many of the important changes in this update were designed to:

1) reduce the number of irrelevant positive results for in vitro mammalian assays, and
2) follow the 3Rs for genotoxicity testing (Replacement, Refinement and Reduction).

Can I use the in vitro micronucleus test as a part of the standard battery?

Yes. ICH states, "Several in vitro mammalian cell systems are widely used and can be considered sufficiently validated: The in vitro metaphase chromosome aberration assay, the in vitro micronucleus assay and the mouse lymphoma L5178Y cell Tk (thymidine kinase) gene mutation assay (MLA). These three assays are currently considered equally appropriate and therefore interchangeable for measurement of chromosomal damage..."

How we can help you:

Use MicroFlow In Vitro kits to analyze hundreds of samples in just a few hours. This flow cytometric method supports both attachment and suspension cell lines.

Next Steps

 

For more information about regulatory
use of In Vitro MicroFlow kits

Click Here

To get a copy of the
ICH S2(R1) regulation

Click Here