An Alternative Developmental Toxicity Screening Capability
Birth defects are the leading cause of infant mortality but approximately 70%of birth defects have no known cause (CDC, 2005). Between 2 and 3% of birth defects are caused by teratogens, or substances that cause birth defects (Finnell, 1999). Pharmaceutical companies screen for developmental toxicity using animal models, yet these screens are only as little as 62% concordant with human response (Reproductive and Developmental Toxicology, 1998). Stemina has developed the first all-human developmental toxicity screen using human embryonic stem (hES) cells and metabolomics: devTOX. Small molecules secreted from hES cells upon teratogen exposure are utilized to form a statistical model of teratogenicity. A test of this model resulted in the prediction of 7 out of 8 (87.5%) of blinded drugs. Stemina is currently translating this assay to a high-throughput format with NSF funding.