Eurotox 2018

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ToxTracker: a unique genotoxicity assay for Mode of Action (MOA) determination of novel pharmaceuticals and chemicals 

Within genetic toxicology there is a well defined battery for testing novel chemicals and pharmaceuticals, however in the last years there is a strong push from both industry and regulators to add genotoxic mode-of-action information. In expert groups such as the IWGT and GTTC at ILSI-Hesi there are ongoing evaluations to adopt these novel mechanistic tests in the current genotoxicity testing battery.  One of the factors driving this development is that mode-of-action information can help to better understand equivocal and potentially misleading positive test results in the standard assays. 

ToxTracker - a mode-of-action assay for genotoxicity 
One mode-of-action assay which is currently being discussed and evaluated by the OECD is the ToxTracker assay. This unique genotoxicity assay that combines multiple fluorescent reporter genes to get mechanistic insight into the of action of genotoxic compounds. The assay not only includes markers for DNA damage, but also markers for non-genotoxic MOA, including oxidative stress and protein damage. The ToxTracker assays fits excellently in the changing landscape and drive for more mechanistic assays in genetic toxicology. Currently a large OECD validation ring trial with 8 expert laboratories is ongoing.

Applications for different industries
Various industries can benefit from adding mode-of-action information to their genotoxicity testing strategy. For Pharma, the ability to discriminate between direct DNA binding of a compound or indirect genotoxicity can be very valuable. Especially, classification of compounds as clastogen or aneugen and ability to properly identify compounds as cell-cycle kinase inhibitor can have important implications for the regulatory dossier. For the Chemical industry, the possibility to identify indirect genotoxicity associated with oxidative stress be be particularly useful to argue a threshold for a genotoxic chemical. Also assessment of secondaire DNA damage related to protein damage and subsequent apoptosis can be valuable to de-risk a compound. Cosmetics industry are not allowed to use animal testing for genotoxicity testing and therefor have to rely on in vitro tests. In absence of animal data, mechanistic information about a cosmetics ingredient is extremely valuable for the proper hazard and risk assessment. Overall, information about the mode-of-action of a (geno)toxic compound can used for read-across and AOP approaches.

Want to learn more about ToxTracker?
Please find us at Eurotox booth 40 to start a conversation on the application of ToxTracker for your projects or visit our posters  P11-16 - The ToxTracker reporter assay detects indirect genotoxicity caused by high levels of oxidative stress  P20-11 - ReproTracker, a Human Stem Cell-Based Reporter Assay for In Vitro DART Assessment

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