devTOXqPTM is a biomarker-based, human, in-vitro assay for prediction of developmental toxicity that utilizes key biomarkers identified using our metabolomics platform.
- Accuracy, sensitivity, and specificity
- Data for multiple exposure levels
- Human test system
- Positive and negative controls on every plate to ensure assay performance
- Rapid turn-around
- Small amount of test compound
“The quality of product/services from the Contractor (Stemina) is rated as exceptional. Contractor 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 to this contractor as they specialize in metabolomics profiling. The Contractor has provided a high level of quality control measures with regard to their data generation as can be effectively validated by the consistency in data between reference compounds and replicate compounds in a blinded study. In each of these areas, the Contractor consistently exceeded performance expectations and successfully delivered timely, high quality, responsive services and products.” – US EPA
Read the full review here.
Table Reference: Palmer JA, Smith AM, Egnash LA, Conard KR, West PR, Burrier RE, Donley EL, Kirchner FR. Establishment and assessment of a new human embryonic stem cell-based biomarker assay for developmental toxicity screening. Birth Defects Res B Dev Reprod Toxicol.
Flexibility Choice of undifferentiated human embryonic stem (hES) cells or induced pluripotent stem (iPS) cells.
Sensitivity and Selectivity The assay is performed using human pluripotent stem cells exposed to eight different concentrations of each test compound to yield a broad look at developmental toxicity potential.
How it Works
- The assay can be performed using just 15 mg of compound.
- The biomarker ratio for eight exposure levels is fitted with a dose-response model.
- A test compound shows developmental toxicity potential where the curve drops below the developmental toxicity threshold dTT.
devTOX DiscoveryTM is a human-based assay developed to predict the potential toxic impact of drugs and other compounds on human embryo/fetal development and offer insight into altered biochemical processes.
devTOX DiscoveryTM provides:
- Metabolomic window into embryonic metabolism impacted by test article.
- Prediction of the potential to cause developmental toxicity.
- Identification of library-matched metabolites changed in response to compound.
- Altered functional pathways associated with developmental toxicity.