Objetivo The aim of the RABIOPRED project is to take the final steps to bring an innovative set of biomarkers that is able to predict response to treatment with TNF-α inhibitors in Rheumatoid Arthritis (RA) to the market and clinical practice. Millions of RA patients are treated with TNF-α inhibiting agents, currently one of the main second-line treatment strategies for RA. These expensive biological RA therapies represent a multibillion market. However, the TNF-α inhibiting agents are not effective in 30-40% of the patients. Clinicians are currently unable to predict the response to this treatment beforehand. The ability to predict response to treatment would greatly improve clinical decision-making, improve health outcomes for RA patients, and contribute to cost reduction and sustainability of the health care system.The RABIOPRED assay is based on a novel gene expression signature and a predictive model, that have been identified and developed by TcLand Expression SA and that have been patented. Proof-of-concept has already been obtained for the prototype biomarker assay. The analytical validation and clinical performance evaluation of the RABIOPRED assay in the current project are the final development steps towards market introduction and clinical application. At the end of this 3.5 year project, a validated and CE registered IVD biomarker assay will be available that is ready for clinical application, initial market introduction and further commercialization and implementation.TcLand Expression SA is a French SME developing biomarkers for personalized medicine and companion diagnostics in immune mediated disorders. TcLand focusses on development and validation of noninvasive multi-gene molecular diagnostic blood tests. TcLand is embedded in an international network of collaborating pharmaceutical companies and clinical centers throughout Europe, facilitating clinical performance evaluation and enhancing subsequent market uptake of novel biomarkers assays. Ámbito científico medical and health sciencesbasic medicinepharmacology and pharmacydrug discoverymedical and health sciencesclinical medicinerheumatologymedical and health scienceshealth sciencespersonalized medicinemedical and health sciencesbasic medicineimmunologyimmunotherapyengineering and technologymedical engineeringmedical laboratory technologylaboratory samples analysis Programa(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Tema(s) PHC-12-2014 - Clinical research for the validation of biomarkers and/or diagnostic medical devices Convocatoria de propuestas H2020-SMEInst-2014-2015 Consulte otros proyectos de esta convocatoria Convocatoria de subcontratación H2020-SMEINST-2-2014 Régimen de financiación SME-2 - SME instrument phase 2 Coordinador FIRALIS MOLECULAR PRECISION SA Aportación neta de la UEn € 4 364 000,00 Dirección 17 RUE DU FORT 68330 Huningue Francia Ver en el mapa Pyme Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención. Sí Región Grand Est Alsace Haut-Rhin Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Participación en los programas de I+D de la UE Opens in new window Red de colaboración de HORIZON Opens in new window Coste total € 4 995 250,00 Participantes (1) Ordenar alfabéticamente Ordenar por aportación neta de la UE Ampliar todo Contraer todo Tercero Entidad jurídica distinta de un subcontratista que está afiliada o vinculada jurídicamente con un participante. Dicha entidad lleva a cabo su trabajo en las condiciones establecidas en el acuerdo de subvención, proporciona bienes o presta servicios para la acción, pero no firma dicho acuerdo. El tercero acata las normas aplicables a su participante en virtud del acuerdo de subvención en lo que respecta a la subvencionalidad de los costes y el control de los gastos. FIRALIS Francia Aportación neta de la UEn € 631 250,00 Dirección RUE DU FORT 35 68330 Huningue Ver en el mapa Pyme Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención. Sí Región Grand Est Alsace Haut-Rhin Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Participación en los programas de I+D de la UE Opens in new window Red de colaboración de HORIZON Opens in new window Coste total € 631 250,00
