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Roche Diagnostics Supports European Union’s DETECTIVE Project to Reduce Animal Testing

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The xCELLigence RTCA System of Roche is being used in the European Union’s DETECTIVE ("Detection of endpoints and biomarkers for repeated dose toxicity using in vitro systems”) Project, a joint study funded by the European Cosmetics Association (Colipa) and the European Commission, where Roche is a member of the consortium.

The DETECTIVE Project encompasses fifteen scientific and commercial partners from different EU states under the leadership of Professor Dr. Jürgen Hescheler from the University of Cologne, a pioneer in producing cardiomyocytes from stem cells.

The goal is to establish a screening pipeline of high content and high throughput, using classical functional genomics, proteomics, and “cellomics” technologies. Ultimately, human biomarkers will be identified and characterized for use in cellular models using repeated dose in vitro testing, in particular for use in the field of cosmetics.

As of March 2009, animal experiments are no longer permitted for use in toxicology testing in the cosmetic industry. Significant progress has been made in recent years to develop alternatives to in vivo toxicity tests for assessing the human safety of new products and product ingredients.

Current conditions do, however, not permit complete replacement of animal testing. This is especially true for the testing of repeated dose effects - the effects of products and ingredients used repeatedly over longer periods of time.

The recently launched xCELLigence RTCA Cardio System will be used for real-time testing of effects in human cardiac cells for these studies. In addition, human renal and hepatic cells will be tested using the xCELLigence RTCA SP Instrument. These Roche Real-time Cell Analyzer (RTCA) Systems use label-free impedance readings to monitor cellular events in real time.

Unlike more complex patch clamping methods, these new systems can be used in a fully controlled environment for continuous monitoring of both short-term and long-term experiments. For more information about these impedance measuring monitoring systems, please visit: www.xcelligence.roche.com.

The DETECTIVE Project is actually one of six separate projects of the SEURAT ("Safety Evaluation Ultimately Replacing Animal Testing") initiative started 1 January 2011, to run five years.

The other projects are SCR & Tox (“Stem Cells for Relevant Efficient Extended and Normalized Toxicology”), HeMiBio (Hepatic Microfluidic Bioreactor), COSMOS (Integrated In Silico Models for the Prediction of Human Repeated Dose Toxicity of COSMetics to Optimise Safety), NOTOX, (Predicting long-term toxic effects using computer models based on systems characterization of organotypic cultures), ToxBank (Supporting Integrated Data Analysis and Servicing of Alternative Testing Methods in Toxicology).

These new approaches apply recent improvements in generating induced pluripotent stem cells from human skin samples for the production of human cells and tissues.

DETECTIVE will initially use human hepatic, cardiac and renal models as common target organs of repeated dose toxicity. This strategy for establishing biomarkers should then be applicable to other organs and organ systems affected by systemic toxicants, and make it possible to define human toxicity pathways for each of the human organs.