Contract research organisation CIT, of Evreux, France has signed an agreement to distribute Stemina’s devTOX assay in Europe and will work with Stemina to validate the test for use under the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) initiative.
As early as 2012, and more particularly for volumes of one ton or more per year, REACH will require manufacturers and importers to register and test all chemicals and compositions containing chemicals. DevTOX uses human Embryonic Stem (hES) cells to test pharmaceuticals, chemicals and formulations such as cosmetics for their potential to cause birth defects if a woman is exposed during pregnancy.
DevTOX is able to model human developmental toxicity with about 90% accuracy in blinded studies of chemicals whose effect on the developing human embryo are known. This is a significant improvement from rodents, which are only about 60% predictive of the effect of a compound on human development.
Located in the University of Wisconsin Research Park in Madison Wisconsin, Stemina developed devTOX by exposing hES cells to a set of drugs, such as Thalidomide, whose effect on the developing human embryo is known and then analysing the metabolic response of the cells using Stemina’s proprietary metabolomics platform technology.
The hES cells were isolated in 1998 by Dr James Thomson at the University of Wisconsin and are approved for use in the US and the EU. Stemina studies the response of hES cells and various cells derived from hES cells, such as heart cells and neurons, to drugs or disease conditions.
CIT is an independent and privately owned contract research organisation (CRO) specialized in safety and health research.
‘We are excited about our partnership with CIT in Europe. Stemina’s cutting edge hES cell based technology combined with CIT’s 40 plus years of experience in toxicology and safety testing is a terrific combination,’ said Stemina ceo, Elizabeth Donley.