Firms will work together to validate the test for use under EC REACH regulations.
CIT – Safety and Health Research Laboratories and Stemina Biomarker Discovery inked a strategic partnership under which CIT will distribute Stemina’s devTOX™ assay in Europe. The firms will also work together to validate the test for use under the European Commission’s REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) initiative. Their partnership in addition will include the development of new technologies for evaluating compound safety.
devTOX is a human embryonic stem cell (hESC)-based approach to testing potential drug toxicity on the human embryo. The approach uses mass spectrometry to analyze the small molecules secreted by hES cells and hES-derived cells including heart and neural cells, in response to drugs, other compounds, injury, or disease. The platform hinges on a novel set of biomarkers that Stemina claims can predict whether the target compound will cause cause birth defects. It says the in vitro platform has an accuracy about 90%, and is also the only system to provide definitive human biomarkers relating to the impact of compounds on human development. Stemina’s hES cells have been approved for use in the U.S. and EU.
While devTOX is Stemina’s flagship product, the firm offers its hES and metabolomics expertise through partnerships in drug development, target identification, and biomarker discovery. Metabolomics services include predictive toxicology, drug development and mechanism of action, and target pathways. The firm also offers mass spectrometry services, and is leveraging its metabolomics expertise in house to develop a newborn screen for diagnosing autism.