Accurate, sensitive, and specific results
The potential of chemical substances to cause prenatal developmental toxicity is commonly assessed based on observations of fetal malformations and variations in rodent or rabbit studies. Such animal studies are costly, resource-intensive, and the results seen in one species often differ from those seen in other species or from those that might be relevant in humans.
devTOX quickPredictTM is a rapid, low-cost alternative to animal studies: it can provide data in only a few weeks at a fraction of the cost of animal testing. It is a human, in vitro assay that utilizes key, predictive biomarkers identified using Stemina’s metabolomics platform with high accuracy. The assay can use either human embryonic stem cells (hESCs) or human induced pluripotent stem cells (iPSCs) to predict developmental toxicity based on changes in cellular metabolism following chemical exposure. The iPSC is a reprogrammed cell that is able to recapitulate development into all cell types like hESCs, but does not come from an embryo.
“[Stemina] provides a key platform in support of EPA’s ToxCast and Virtual Tissue Model programs, including an assay on human embryonic stem cell metabolism that is highly unique … as they specialize in metabolomics profiling. [Stemina] consistently exceeded performance expectations and successfully delivered timely, high-quality, responsive services and products.”
devTOX quickPredictTM PROCESS
devTOX quickPredictTM ACCURATELY PREDICTS HUMAN RESPONSE
devTOX quickPredictTM is as predictive of human toxicity as the required in vivo tests and more predictive than other alternative assays.
| Model System | Number of Compounds | Model Accuracy** | devTOX qP TM Accuracy** |
|---|---|---|---|
| Rodent* | 35 | 86% | 89% |
| Rabbit* | 28 | 79% | 86% |
| Mouse EST | 23 | 74% | 91% |
| Zebrafish | 24 | 75% | 92% |
| Whole Embryo Culture | 26 | 73% | 96% |
All values based on literature review of other systems and known / suspected human developmental toxicants.
*Current required in vivo tests
**Assay accuracy compared to suspected human developmental toxicity potential
devTOX quickPredictTM Results Interpretation
- Toxicity is a function of exposure
- Identify exposure level that alters metabolism
- Developmental Toxicity Threshold: Level of change in O/C ratio associated with developmental toxicity.
- Developmental Toxicity Potential: Test compound concentration predicted to be associated with developmental toxicity.
- Changes in the O/C ratio can be compared to cell viability.
- Determine non-toxic and toxic exposure windows
Why devTOX quickPredictTM
Flexibility
Choose undifferentiated human embryonic stem (hES) cells or induced pluripotent stem (iPS) cells.
Sensitivity and Selectivity
The assay is performed using cells exposed to eight different concentrations of each test article, which offers a broader look at developmental toxicity potential.
Assay Validation
Our assay has been internally validated with more than 80 compounds with published human / in vivo developmental toxicity data.
How it Works
SUBMIT SAMPLES FOR TESTING WITH THE SAMPLE SUBMISSION FORM
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