Objective 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. Fields of science 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 Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) PHC-12-2014 - Clinical research for the validation of biomarkers and/or diagnostic medical devices Call for proposal H2020-SMEInst-2014-2015 See other projects for this call Sub call H2020-SMEINST-2-2014 Funding Scheme SME-2 - SME instrument phase 2 Coordinator FIRALIS MOLECULAR PRECISION SA Net EU contribution € 4 364 000,00 Address 17 RUE DU FORT 68330 Huningue France See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Grand Est Alsace Haut-Rhin Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 4 995 250,00 Participants (1) Sort alphabetically Sort by Net EU contribution Expand all Collapse all Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. FIRALIS France Net EU contribution € 631 250,00 Address RUE DU FORT 35 68330 Huningue See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Grand Est Alsace Haut-Rhin Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 631 250,00
