In 2015, a preliminary inter-laboratory validation study already indicated an excellent transferability and reproducibility. Now, in a large international validation study, together with seven expert laboratories, Toxys is determined to confirm the outstanding performance and added value of the ToxTracker assay. The validation study is initiated in parallel to the recent initiatives towards the European Center for Validation of Alternative Methods (ECVAM) and the Organisation for Economic Cooperation and Development (OECD) and should contribute to regulatory acceptance of the ToxTracker assay.
About the study
The consortium of consists of 7 multinational corporations in the field of health care and consumer products, the pharmaceutical industry and international CRO’s with additional support provided by several experts in the field of genotoxicity and cancer hazard assessment. In accordance with the OECD guidance document on the validation of new test methods, the ToxTracker assay will be installed in each of the participating laboratories. After a technical training , each lab will independently test a significant selection chemicals for their hazardous and genotoxic properties.
The results from the participating labs will use to determine the transferability, intra- and interlab reproducibility. The outcomes from this international study will be published at the end of the project. Giel Hendriks:
We are very proud to bring together such a strong consortium with key opinion leaders in our field and demonstrate the reproducibility and predictive capacity of our ToxTracker assay in this extended study.
ToxTracker is an unique, stem cell-based reporter assay for genotoxicity and cancer hazard assessment, that combines multiple biomarkers to get mechanistic insight into the of action of genotoxic compounds. A major advantage of ToxTracker is that it not only includes markers for induction of DNA damage, but also reporters for a non-genotoxic mode-of-action like oxidative stress and protein damage. All these types of cellular damage have been associated with increased cancer risk.