Is the MicroFlow method acceptable for regulatory testing?
Yes, the FDA accepts MicroFlow data. Additionally, the most current Organization for Economic Co-Operation and Development (OECD) guideline regarding micronucleus testing (Guideline 474) indicates that flow cytometry is an acceptable alternative to manual evaluation. Furthermore, when analyses are performed using Litron’s recommended procedures, the MicroFlow process meets all of the necessary validation criteria as described by the IWGTP (International Workshop on Genotoxicity Test Procedures).
