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The Vitotox and ToxTracker assays: A two-test combination for quick and reliable assessment of genotoxic hazards.

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Title: The Vitotox and ToxTracker assays: A two-test combination for quick and reliable assessment of genotoxic hazards.
Authors: Ates, Gamze1 gamze.ates@vub.ac.be, Favyts, Dorien1, Hendriks, Giel2, Derr, Remco2, Mertens, Birgit3, Verschaeve, Luc3, Rogiers, Vera1, Y. Doktorova, Tatyana3
Source: Mutation Research - Genetic Toxicology & Environmental Mutagenesis. Nov2016, Vol. 810, p13-21. 9p.
Subject Terms: *Genetic toxicology, *Drug additives, Vinblastine, Biliverdin, Chromosome abnormalities
Abstract: To ensure safety for humans, it is essential to characterize the genotoxic potential of new chemical entities, such as pharmaceutical and cosmetic substances. In a first tier, a battery of in vitro tests is recommended by international regulatory agencies. However, these tests suffer from inadequate specificity: compounds may be wrongly categorized as genotoxic, resulting in unnecessary, time-consuming, and expensive in vivo follow-up testing. In the last decade, novel assays (notably, reporter-based assays) have been developed in an attempt to overcome these drawbacks. Here, we have investigated the performance of two in vitro reporter-based assays, Vitotox and ToxTracker. A set of reference compounds was selected to span a variety of mechanisms of genotoxic action and applicability domains ( e.g ., pharmaceutical and cosmetic ingredients). Combining the performance of the two assays, we achieved 93% sensitivity and 79% specificity for prediction of gentoxicity for this set of compounds. Both assays permit quick high-throughput analysis of drug candidates, while requiring only small quantities of the test substances. Our study shows that these two assays, when combined, can be a reliable method for assessment of genotoxicity hazard. [ABSTRACT FROM AUTHOR]
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Abstract:To ensure safety for humans, it is essential to characterize the genotoxic potential of new chemical entities, such as pharmaceutical and cosmetic substances. In a first tier, a battery of in vitro tests is recommended by international regulatory agencies. However, these tests suffer from inadequate specificity: compounds may be wrongly categorized as genotoxic, resulting in unnecessary, time-consuming, and expensive in vivo follow-up testing. In the last decade, novel assays (notably, reporter-based assays) have been developed in an attempt to overcome these drawbacks. Here, we have investigated the performance of two in vitro reporter-based assays, Vitotox and ToxTracker. A set of reference compounds was selected to span a variety of mechanisms of genotoxic action and applicability domains ( e.g ., pharmaceutical and cosmetic ingredients). Combining the performance of the two assays, we achieved 93% sensitivity and 79% specificity for prediction of gentoxicity for this set of compounds. Both assays permit quick high-throughput analysis of drug candidates, while requiring only small quantities of the test substances. Our study shows that these two assays, when combined, can be a reliable method for assessment of genotoxicity hazard. [ABSTRACT FROM AUTHOR]
ISSN:13835718
DOI:10.1016/j.mrgentox.2016.09.005