The Institute for In Vitro Sciences (IIVS) and Toxys have entered into a license agreement that allows IIVS to offer the ToxTracker assay. ToxTracker is an innovative in vitro assay allowing identification of the genotoxic and potentially carcinogenic properties of novel and existing drugs, (agro)chemicals, cosmetics and other substances without the use of animal testing.

ToxTracker is a unique stem cell-based reporter assay for reliable genotoxicity and carcinogenicity hazard identification. In addition to highly reliable detection of genotoxic compounds, the ToxTracker assay provides insight into the mode-of-action of genotoxicity. The assay can discriminate between direct DNA reactivity and indirect genotoxicity related to oxidative stress or protein damage and can identify clastogenic and aneugenic compounds. Various extensions of ToxTracker are available to further investigate the mode-of-action of genotoxic compounds. Utilization of the ToxTracker assay can help mitigate risk of regulatory rejection by demonstrating the exact mechanism of genotoxicity.

ToxTracker has been extensively validated using various reference compound libraries recommended by international governmental organizations. ToxTracker is currently under review for regulatory acceptance and has already been applied across the pharmaceutical, agrochemical and consumer product industries for regulatory applications.

Toxys is providing IIVS with the materials and training needed to achieve proficiency and expertise in applying this technology as a service. With an anticipated availability in mid-May, IIVS will become the first Contract Research Organization to offer ToxTracker at a US-based laboratory.

“At IIVS we recognize the need for mechanistically-based methods to inform industry and regulatory stakeholders well beyond the basic hazard assessment tools. Hence, we feel the ToxTracker suite contributes exceptionally well to IIVS’ information-rich testing service philosophy, and we couldn’t be more pleased to partner with the scientific leadership at Toxys to optimize value to our stakeholders,” said Hans Raabe, COO of IIVS.