THERADIAG selected as a partner of the ABIRISK project, the first consortium of pharmaceutical and academic experts dedicated to the monitoring of biotherapies
ABIRISK will use Lisa-Tracker theranostics kits to investigate the risks of immunogenicity generated by innovative biopharmaceuticals
Croissy-Beaubourg and Montpellier, March 21 2014 – Theradiag (ISIN: FR0004197747, Ticker: ALTER), a company specializing in theranostics and in vitro diagnostics, is proud to announce that it has been selected by the European pharmaceutical and academic consortium ABIRISK (Anti-Biopharmaceutical Immunization: prediction and analysis of clinical relevance to minimize the RISK) to participate in the evaluation of immunogenicity risks linked to existing biotherapies. Theradiag will provide Lisa-Tracker theranostics kits for 3 years as part of the project.
Theradiag conducted successfully over 5 000 analyses and validation tests in order to meet the sensitivity and accuracy requirements of the consortium.
”We are proud to have been selected by the ABIRISK consortium. Being a partner of ABIRISK is a clear validation by pharmaceutical and scientific experts of our products and expertise. Lisa-Tracker is one of the best-performing products currently on the market for the monitoring of biotherapies in auto-immune and inflammatory diseases” comments Michel Finance, CEO of Theradiag.
”ABIRISK is a unique initiative in Europe, whose goal is to evaluate the immunogenicity of existing biopharmaceutical products. To do so, the consortium needs accurate and sensitive tests to monitor the development of anti-drug antibodies throughout the treatment. Greater harmonization of the monitoring of treatments, and thereby standardization and characterization of anti-drug antibodies, is one of the main objectives of ABIRISK” added Marc Pallardy, academic coordinator of ABIRISK, INSERM and Université Paris-Sud.
ABIRISK is a joint project of the European pharmaceutical industry, universities and research institutes, which aims at monitoring the development of anti-drug antibodies (ADAs) and neutralizing antibodies (Nab) and their effect on patients treated with biotherapies. ABIRISK marks the recognition by the pharmaceutical industry and the actors of the European healthcare system of the risks generated by the immunogenicity of monoclonal antibodies and recombinant proteins.
A clinical study will be conducted as part of the project on several large cohorts of European rheumatoid arthritis and Crohn’s Disease patients. The dosage of ADAs will be done exclusively through the use of Lisa-Tracker kits. These prospective cohorts will recruit patients who have not been treated with biotherapies.
The European project ABIRISK is the collaboration between the European Federation of Pharmaceutical Industries, the Innovative Medicine Initiative (IMI), and the European Union. It counts 39 partners : large members of the pharmaceutical industry (Pfizer, GSK, Sanofi-Aventis, Merck, UCB, Ipsen, Novartis, Novo Nordisk, Bayer), academic labs and reserach institutes (INSERM, CNRS, CEA, University College London, Karolinska Institute, Leiden University) universities and university hospitals. The ABIRISK project’s goal is to provide an integrated approach to anti-drug immunization, bringing together, in an extensive and coordinated manner, a large network of clinicians from various specialties with broad experience in the care of patients treated with various type of biopharmaceutical products and developing anti-drug antibodies, biologists familiar with the immune monitoring of patients, scientists specialized in the mechanisms of immunogenicity, methodologists and biostatisticians. It will ensure direct transfer of the experimental findings into biopharmaceutical products development and patient management. The project will cost €34.9 million and last 60 months. More information at www.abirisk.eu
Capitalizing on its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostics tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag is thus participating in the development of “customized treatment”, which favors the individualization of treatments, the evaluation of their efficacy and the prevention of drug resistance. Theradiag market the Lisa-Tracker range (CE marked), which is a comprehensive multiparameter theranostic solution for patients with autoimmune diseases treated with biotherapies. With its subsidiary Prestizia, Theradiag is also developing new diagnostics biomarkers thanks to its microRNA platform, in order to diagnose and monitor HIV/AIDS and rectal cancer. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has over 60 employees.
For more information about Theradiag, please visit our website: www.theradiag.com
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