Bringing Animal-Free Developmental Toxicity Testing One Step Closer to Regulatory Acceptance

Leiden, Netherlands – Toxys is proud to announce that it has been awarded funding through the ValNAM Call, a collaborative initiative launched by the German Federal Ministry of Research, Technology and Space (BMFTR) and ZonMw, the Dutch organization for health research and innovation.

The ValNAM program aims to accelerate the adoption of animal-free, human-relevant New Approach Methodologies (NAMs) by ensuring robust validation and supporting their path to regulatory acceptance.

“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.”

Advancing ReproTracker® for Developmental Toxicity Assessment

ReproTracker monitors the differentiation of human stem cells into three germ-layer-specific cell types:

• Cardiomyocytes (heart cells)
• Hepatocytes (liver cells)
• Neural progenitor cells (early nervous system cells)

By analyzing key biomarker expression patterns alongside cellular morphology and functionality, ReproTracker enables highly accurate assessment of the teratogenic potential of pharmaceuticals, chemicals, and other compounds.

ReproTracker has been validated in-house using both ICH S5 (3R) and EURL ECVAM reference compound libraries, identifying the developmental toxicity potential of new drugs and chemicals with 85% accuracy.

Consortium Partners and Goals

The project brings together a leading consortium of industry partners, academic institutions, and research organizations with broad expertise in alternative methods and 3Rs:

• Ombion (Centre for Animal-free Biomedical Translation)
• Unilever
• DNTOX
• German Federal Institute for Risk Assessment (BfR)
• Adriaens Consultancy

Together, the consortium will conduct inter-laboratory validation of ReproTracker, including transferability and reproducibility studies, and demonstrate its potential for developmental toxicity testing.

Read more about ValNAM here.

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