STEMINA BIOMARKER DISCOVERY INC.

Company Overview

Stemina describes itself as the global leader in building human cellular models for toxicity screening of drug candidates, chemical compounds, cosmetic and tobacco ingredients; its developmental toxicity assays are the only human system for assessing the risk that a compound will cause birth defects if a woman is exposed during pregnancy.

Stemina is a metabolomic company focused on the discovery, development, and commercialization of molecular biomarkers to improve drug safety and human health. Stemina’s cell-based assays arise from the strategic convergence of two cutting-edge technologies: human embryonic stem (hES) cells and metabolomics. Stemina uses mass spectrometry to analyze the small molecules secreted by hES cells and differentiated cells such as heart and neural cells made from hES cells in response to drugs, injury, or disease. Stemina opened its state-of-the-art facilities for hES cell culture and mass spectrometry in the UW Research Park in Madison, Wis., on Nov. 1, 2007.

Stemina’s Flagship product is devTOX, which the company describes as the first and only all-human-based screen for assessing the toxicity of drugs and chemical compounds on human development. In February 2011, CIT Safety and Health Research Laboratories and Stemina entered 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 Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) initiative. Their partnership will also 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 (e.g., heart cells, 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 birth defects. The company says the in vitro platform has an accuracy of approximately 90%, and it 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 E.U.

Company's Business Segments

• Stemina : This business unit focused on toxicology.
• NeuroPointDX : This business unit focused on the diagnosis and treatment of neurological disorders such as autism spectrum disorder.