CROISSY-BEAUBOURG, France & MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
THERADIAG (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), a company specialized in in vitro diagnostics and theranostics, announced today that it has obtained CE marking for its Entyvio® (vedolizumab) monitoring kit, expanding its Lisa Tracker® range.
Professor Gérard Tobelem, Chairman of Theradiag’s Board of Directors and former Chairman of France’s National Blood Bank, commented: “This latest CE marking allows us to cover all the biotherapies available to treat inflammatory bowel disease (IBD). 2015 was a very fruitful year, with three approvals of products in the Lisa Tracker® range. As a result, Theradiag confirms its leadership position in theranostics for inflammatory conditions.”
Entyvio®/vedolizumab is a humanized monoclonal antibody that binds specifically to α4-β7 integrin, a key molecule dispatching lymphocytes – immune system cells – to the digestive tract. This molecule reduces the unusually high recruitment of lymphocytes during inflammatory bowel diseases, thereby reducing bowel inflammation. Vedolizumab is indicated in the treatment of Crohn’s disease and moderately to severely active ulcerative colitis in adult patients presenting insufficient response, loss of response or intolerance to a conventional treatment or by anti-TNFs.
This molecule, which comes from a new therapeutic class with a different
mechanism of action from the anti-TNFs, is the fourth available in the
United States and the third in Europe for inflammatory bowel disease.
Theradiag is the only company to offer monitoring of these four biotherapies.
This is the 11th CE-marking obtained by Theradiag for its Lisa Tracker® range in the last few years. It strengthens the Lisa Tracker® range – the most extensive range of monitoring kits for biotherapies currently available in the market.
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 notably markets 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 developing new biomarkers based on microRNAs for the diagnosis and monitoring of rectal cancer, auto-immune and inflammatory diseases and HIV/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. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has over 75 employees.
For more information about Theradiag, please visit our website: www.theradiag.com