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The following conclusion was agreed under matters arising at the February 1999 meeting of the Committee. Introduction The Comet (single cell gel electrophoresis) assay had been proposed by several research groups as a rapid in-vivo assay for detecting genotoxicity at multiple sites. In 1995 the Committee assessed all the available published literature on the use of this assay to detect chemical mutagens. The Committee agreed, at that time, that the methods used in the 'Comet assay' represented an interesting research area but further research work was required before the significance of results from this assay could be interpreted. Members understood that a major investigation had recently been completed by a Japanese research group and agreed to review the results when published in the scientific literature. Conclusions 1. Although much work has been carried out on the development of the Comet assay since 1995, further work on optimising methodology, and then on validation (to assess robustness and reliability) are needed before the method can routinely be used for regulatory purposes. 2. Although work on optimising methodology can be based on the in vitro assay, the main value of this assay for genotoxicity testing is the potential to provide a simple in vivo assay that may be used in a range of tissues including non-dividing cells. 3. The method does have the potential to provide useful supplementary data on a case by case basis to provide data to compliment the in vitro and in vivo package of tests. In particular such studies may provide valuable information on direct and indirect mechanisms of DNA damage in target tissues. References 1. Fairburn DW, Olive PL, and O'Neill KL (1995). The Comet assay: a comprehensive review. Mutation Research, 339, 37-59. 2. Anderson D and Plewa MJ (1998). The International Comet Assay Workshop. Mutagenesis, 13, 67-73. 3. Henderson L, Wolfreys A, Fedyk J, Bourner C and Windebank S (1998). The ability of the Comet assay to discriminate between genotoxins and cytotoxins. Mutagenesis, 13, 89-94.
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