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 per cent 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 per cent predictive of the effect of a compound on human development.
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 analyzing the metabolic response of the cells using Stemina’s proprietary metabolomics platform technology. The hES cells, isolated in 1998 by Dr. James Thomson at the University of Wisconsin and approved for use in the United States and the European Union, offer a unique opportunity to understand human development and the impact of birth defect causing agents on the developing embryo.
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. “We are excited about our partnership with CIT in Europe. Stemina’s cutting edge hES cell based technology combined with CIT’s more than 40 years of experience in toxicology and safety testing is a terrific combination,” says Stemina CEO, Elizabeth Donley.
CIT is an expert in high quality preclinical development of pharmaceuticals, chemicals and consumer products. At CIT’s state-of-the-art facilities in Evreux, France, less than one hour from Paris, Stemina and CIT will validate the devTOX assay for use under the REACH initiative and develop additional innovative technologies for evaluating the safety of compounds for animal and human use.
“CIT is very excited about its strategic investment and partnership with Stemina especially because of its expertise in the important and cutting edge field of stem cells and metabolomics,” said Dr Roy Forster, CSO of CIT. “The partnership offers an opportunity for unique approaches to assessing the safety of candidate drugs, chemicals and consumer products. Working with Stemina, we will assure that our clients have access to the most innovative technology for evaluating the toxicity and safety of compounds.”