Toxys awarded funding through ValNAM to accelerate regulatory acceptance of ReproTracker

10 June 2026

Leiden-based Toxys announces that it has been awarded funding through the ValNAM Call, a collaborative initiative to validate and implement new approach methodologies in a regulatory context, launched by the German Federal Ministry of Research, Technology and Space (BMFTR) and ZonMw, the Dutch organization for health research and innovation.

One of Toxys' main areas of focus is developmental toxicology, that assesses whether parental or gestational exposure to a substance can cause adverse effects in developing embryos. These effects may result in structural malformations, functional deficits, growth retardation, premature birth or death, often reflecting disruptions in organogenesis and tissue maturation.   

Typically, the potential for developmental toxicity is assessed in pregnant animals, however, owing to numerous inter-species differences, including in physiology and developmental timings, the positive and negative predictive values of developmental toxicity testing in animals are poor - close to the 50% chance of predicting whether a chemical is safe by simply tossing a coin.

In addition, toxicity testing uses and a high number of animals and takes years to finalize, precluding complete risk assessment of tens of thousands of substances in use.

Accordingly, there is a high demand for human-based in vitro assays that rapidly and reliably identify developmental toxicity hazards. Specifically, to predict teratogenicity in humans, Toxys Reprotracker measures changes in human induced pluripotent stem cells (hiPSC) differentiation, morphology, function and biomarker expression.  

“The ValNAM platform will undoubtedly help bring ReproTracker one step closer to regulatory acceptance, and we are excited for what comes next” said Dr. Amer Jamalpoor, CSO at Toxys. “This project enables us to generate and demonstrate the assay’s reliability in predicting human developmental toxicants. We believe this initiative will contribute to the broader acceptance of human-relevant, animal-free testing strategies and help accelerate the transformation of developmental toxicity assessment worldwide.”

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