ToxTracker® Approved by OECD for Incorporation into Test Guideline Programme

OEGSTGEEST, the Netherlands, September 04, 2025 / Biotech Newswire / — Toxys, a leading innovator in animal-free toxicology solutions, announces that its flagship product, ToxTracker®, has been accepted into the Organization for Economic Co-operation and Development (OECD) Test Guidelines Programme. This milestone marks a significant step toward global regulatory recognition and commercial expansion of ToxTracker.
The original approval by OECD to start the development of this Test Guideline followed an extensive multi-year international inter-laboratory validation. The OECD has now published the draft ToxTracker Test Guideline for public consultation. Full OECD approval is expected to unlock widespread regulatory acceptance across many industries and regulatory bodies and allow users to include genotoxicity data from ToxTracker into regulatory submissions.

The ToxTracker assay was developed in-house by Toxys and is an in vitro method that accurately predicts the genotoxic potency of substances. The assay is widely used for chemical safety testing without the use of animals and is already included by various industries into their regulatory applications. ToxTracker provides insight into the mode of action of genotoxic compounds thereby significantly improving the in vitro safety assessment of novel pharmaceutical products, agrochemicals, chemicals, cosmetics and food-related products. The OECD’s endorsement confirms the positioning of ToxTracker in next-generation genotoxicity testing. The assay also aligns with strong international pressure and ambitions to reduce animal testing.

“OECD’s endorsement of ToxTracker is a transformative moment for Toxys and the future of toxicology. It validates our scientific approach and opens the door to global regulatory markets. We remain committed to delivering innovative, animal-free safety solutions that meet the highest standards of reliability and ethics” – Giel Hendriks, CEO of Toxys. 

Link to the press release

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.

About Toxys
Toxys is a biotechnology company with headquarter in the Netherlands, dedicated to improving chemical safety through innovative, animal-free testing solutions. Toxys develops advanced in vitro assays that help identify toxic, carcinogenic and reproductive toxicological properties of chemicals early in development. The flagship product, ToxTracker, is widely used in the pharmaceutical, chemical, and cosmetics industries to reduce reliance on animal testing and improve safety assessments. The broad portfolio of unique in vitrotoxicology assays also includes the ReproTracker® and ToxProfiler® assays.
With a strong commitment to scientific excellence and sustainability, Toxys is shaping the future of toxicology by offering reliable, ethical, and cost-effective alternatives for safety testing. The company collaborates with leading research institutions and regulatory bodies worldwide and continues to expand its global footprint through strategic partnerships and product innovation.

Contact

Toxys
Paula van Rossum
+31 71 3322470
p.vanrossum@toxys.com