Objective Every year ~ 40.000 patients throughout the EU are transplanted a new kidney, lung, liver, heart or another organ. The frequency of clinical complications is relatively high because at present there are no diagnostic tests that help physicians to determine the right dosage of immunosuppressive drugs necessary to avoid both organ rejection and clinical complications caused by infections. Lophius Biosciences GmbH has developed I-Scan, a functional immune monitoring test that within 24 h provides important information on the strength of the immune system in solid organ transplant recipients. I-Scan uses a proprietary cocktail of stimulants that selectively stimulate the clinically relevant immune cells in a patient’s blood sample. The detection of the triggered interferon γ (IFN-γ) release provides a qualitative and quantitative measurement of cell-mediated immune function.The feasibility study performed during Phase 1 will explore issues related to both, the clinical biomarker validation study and the best market entry strategy. Several objectives are pursued in parallel and encompass: • Setting up the business plan which includes a competitor as well as a freedom-to-operate analysis and a market entry strategy.• Selection of clinical study partners and defining the design of the clinical study, best suited to yield highest clinical evidence• Obtaining regulatory approval for the planned clinical study and setting a strategy to obtain regulatory approval / CE-Marking for final I-Scan products.Lophius will apply for Phase 2 funding of a clinical study to validate that I-Scan improves the outcome of SOT patients. This study is likely to take place in Germany, Switzerland and Austria where Lophius has already established firm links to transplantation centers. The study is the logical next step to further grow Lophius to become a global leader in the IVD market for immunomonitoring Fields of science medical and health sciencesbasic medicineimmunologymedical and health sciencesmedical biotechnologycells technologiesstem cellsmedical and health sciencesclinical medicinetransplantation 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-12-2015-1 - 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-1-2015 Funding Scheme SME-1 - SME instrument phase 1 Coordinator LOPHIUS BIOSCIENCES GMBH Net EU contribution € 50 000,00 Address AM BIOPARK 13 93053 REGENSBURG Germany 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 Bayern Oberpfalz Regensburg, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 71 429,00
