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Updated: Dec 28, 2025
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Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
Published on: June 17, 2015
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Profiling the ToxCast Library With a Pluripotent Human (H9) Stem Cell Line-Based Biomarker Assay for Developmental
Todd J Zurlinden1, Katerine S Saili1, Nathaniel Rush1
1National Center for Computational Toxicology (NCCT).
Summary
The Stemina devTOX quickPredict platform, using human pluripotent stem cells, screened 1065 chemicals for developmental toxicity. The assay showed 79%-82% accuracy, aiding in predicting in vivo toxicants from in vitro data.
Area of Science:
- Toxicology
- Biomarker Discovery
- Stem Cell Assays
Background:
- Developmental toxicity screening is crucial for human health.
- Existing methods often rely on animal models.
- Novel in vitro assays are needed for efficient screening.
Purpose of the Study:
- To evaluate the Stemina devTOX quickPredict platform for developmental toxicity prediction.
- To screen a large set of chemicals using this human pluripotent stem cell-based assay.
- To assess the assay's performance against in vivo data.
Main Methods:
- Screened 1065 ToxCast chemicals using the Stemina (STM) assay.
- Measured the ratio of ornithine to cystine as a biomarker.
- Compared STM assay predictions with in vivo animal models of developmental toxicity.
Main Results:
- 19% of screened chemicals predicted developmental toxicity.
- Assay achieved 79%-82% accuracy with high specificity (>84%) but modest sensitivity (<67%).
- Sensitivity improved with more stringent evidence requirements for animal studies.
Conclusions:
- The Stemina devTOX quickPredict platform shows promise for predicting in vivo developmental toxicants.
- In vitro data from this assay can complement in silico models for risk assessment.
- Further refinement can enhance the prediction of developmental toxicity.
