Environmental and Molecular Mutagenesis (EMM) Editor's Choice - October 2013
The Editor's Choice for October is “The Holy Grail in Genetic Toxicology: Follow-Up Approaches for Positive Results in the Ames Assay” by Marilyn Aardema, the 2012 Alexander Hollaender Award Winner.
In her article, Dr. Aardema draws attention to the Ames positive hurdle, noting that most Ames positive tests are simply dropped from further development. Dr. Aardema points out that because of this, knowledge regarding the relevance to humans of Ames test positive chemicals is falling behind that of chemicals that are positive in other in vitro genotoxicity assays. Dr. Aardema’s review delineates the state-of-the-science as to what different expert and regulatory groups recommend in terms of following-up studies for Ames positive results. Specifically, Dr. Aardema has extracted and summarized recommendations and interpretations from the guidances provided by the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI), the European Center for Validation of Alternative Methods (ECVAM), the International Conference on Harmonisation (ICH)S2(R1) guidance, the International Conference on Harmonisation (ICH) M7 guidance, and the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) 2012 guidelines. The article concludes with suggestions for mitigating a positive Ames assay result, which Dr. Aardema proffers as a starting point for stimulating future discussions and more rapid progress in developing practical approaches for dealing with Ames positive results. Environ.Mol. Mutagen. 54:617–620, 2013. © 2013 Wiley Periodicals, Inc.