Objective The French SME Amoneta Diagnostics has previously developed a diagnostic kit for Alzheimer’s disease (AD) based on two blood biomarkers that are scientifically proven to be associated with AD. The company holds the intellectual property for specific fluorescent probes that can detect these biomarkers in small amounts of blood using flow cytometry. Currently, no single test to diagnose AD exists. A potential AD diagnosis is usually given by a combination of clinical examination, neuropsychological tests and brain imaging over weeks/months. A lumbar puncture can be performed to detect biomarkers in cerebrospinal fluid, but this procedure is risky and expensive. A definite AD diagnosis can formally only be given by autopsy. Consequently, the diagnosis is assessed late and still questionable. The novel kit allows the diagnosis of AD, using only one single test, in a fast, non-invasive and inexpensive way. We expect the blood-based biomarker kit to facilitate assessment of drug efficacy in AD drug development and the monitoring of treatment efficacy in AD patients. This kit will meet the urgent medical need of ~2 million patients in Europe, Japan and America, that are annually diagnosed with AD. Successful implementation will have a strong impact on the quality of life of patients and a significant impact on the healthcare system and economy.In this project, Amoneta Diagnostics will validate this diagnostic test by performing a Proof-of-Performance (PoP) clinical study in 800 human subjects including 400 AD patients. At the end of this 3-year project, a validated and CE registered IVD biomarker assay will be available and ready for clinical application. This innovative ADDIA biomarker assay will be ready for initial market introduction and further commercialization and implementation. The project is supported by patient organisation Alzheimer Europe, and several leading European Alzheimer centres that are committed to enrol subjects for the PoP clinical study. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacydrug discoverymedical and health sciencesbasic medicineneurologydementiaalzheimermedical and health sciencesbasic medicinepathologynatural sciencesbiological sciencesgeneticsRNAengineering 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 AMONETA DIAGNOSTICS Net EU contribution € 4 194 270,50 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 Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 4 998 625,00 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 € 804 354,50 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 € 804 354,50
