Toxys announces the peer-reviewed publication of the positive results from an international interlaboratory validation of ToxTracker?. ToxTracker is an in vitro method that accurately predicts genotoxicity without the use of animals. The results constitute an essential part of the approval process by the OECD for international acceptance of novelmethods by regulatory authorities. The evaluation was finalized earlier in the year and data have been submitted to the OECD showing that ToxTracker consistently demonstrates high accuracy and excellent reproducibility of test results, both within and between different laboratories. These data prove that ToxTracker is both robust and reliable. Importantly,ToxTracker can provide insight into the mode of action of genotoxic compounds thereby significantly improving the in vitro safety assessment of novel pharmaceutical products, chemicals, cosmetics and food-related products.

Short background on the validation

The purpose of this study was to validate transferability, robustness and reproducibility of the assay, demonstrate the accuracy of ToxTracker to predict in vivo genotoxicity, and to assess if the mechanistic information from the assay can improve current in vitro genotoxicity testing strategies. The comprehensive evaluation of ToxTracker, was carried out in seven different independent laboratories (Corteva Agriscience, USA; Charles River Laboratories,Canada; Genentech, USA; Labcorp, United Kingdom; Pfizer, USA; Procter & Gamble, USA; Hoffmann-La Roche, Switzerland) using various reference compound libraries recommended by international governmental organizations. The laboratories carried out ToxTrackerindependently in a blinded manner using 64 chemicals in accordance with OECD guidance document 34.
The results of the validation are presented in the scientific publication “Interlaboratory validation of the ToxTracker assay: “Anin vitro reporter assay for mechanistic genotoxicity assessment” by G. Hendriks et al.  that was recently published in Environmental and Molecular Mutagenesis.
"The publication of the ToxTracker validation is a major milestone for the assay and for Toxys. We are fully dedicated to developing and validating innovative in vitro assays to improve the safety assessment of novel medicines and otherproducts without the use of animals. Completion of the validation will further accelerate the adoption of ToxTracker in regulatory applications." – Giel Hendriks, CEO of Toxys.

About ToxTracker

ToxTracker is a unique stem cell-based reporter assay for reliable genotoxicity hazard identification. Additionally, ToxTracker provides insight into genotoxic mode-of-action as the assay can discriminate between direct DNA reactivity and indirect genotoxicity related to oxidative stress or protein damage. Furthermore, ToxTracker can be used to discriminate clastogens from aneugens by using one of the various assay extensions (i.e., ToxTracker ACE). Utilization of the ToxTracker platform can help mitigate the risk of regulatory rejection by demonstrating the exact mechanism of genotoxicity.