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CIT, Stemina Ink Distribution Deal for Stem Cell-based Assay

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – CIT and Stemina Biomarker Discovery today announced a deal for the distribution of Stemina's assay in Europe and validation of the assay under European regulations for the production and use of chemical substances.

CIT will distribute Stemina's devTOX assay and validate the test under the Registration, Evaluation, Authorization, and Restriction of Chemicals, or REACH, initiative, which starting as early as next year will require manufacturers and importers to register and test all chemicals and compositions containing chemicals.

The devTOX assay uses human embryonic stem cells to assess the effect of drugs and chemicals on human development. In a statement, Stemina said the assay tests chemicals such as those found in cosmetics for their potential to cause birth defects if a woman is exposed during pregnancy.

In blinded studies of chemicals whose effects on developing human embryo are known, devTOX has been able to model human developmental toxicity with about 90 percent accuracy. By comparison, models based on rodents have about 60 percent accuracy, the two companies said.

CIT and Stemina will validate devTOX in CIT's facilities in Evreux, France, and develop other technologies for the evaluation of compounds for animal and human use.

Financial and other terms of the agreement were not disclosed.

CIT is a contract research organization specializing in safety and health research. Stemina, headquartered in Madison, Wis., is a metabolomics firm discovering, developing, and commercializing molecular biomarkers for drug safety and human health. In May 2010, it partnered with Agilent Technologies to help build out Stemina's capabilities while strengthening Agilent's presence in the metabolomics field.

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