Objectif 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. Champ scientifique 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 Thème(s) PHC-12-2014 - Clinical research for the validation of biomarkers and/or diagnostic medical devices Appel à propositions H2020-SMEInst-2014-2015 Voir d’autres projets de cet appel Sous appel H2020-SMEINST-2-2014 Régime de financement SME-2 - SME instrument phase 2 Coordinateur AMONETA DIAGNOSTICS Contribution nette de l'UE € 4 194 270,50 Adresse 17 RUE DU FORT 68330 HUNINGUE France Voir sur la carte PME L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention. Oui Région Grand Est Alsace Haut-Rhin Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Liens Contacter l’organisation Opens in new window Participation aux programmes de R&I de l'UE Opens in new window Réseau de collaboration HORIZON Opens in new window Coût total € 4 998 625,00 Participants (1) Trier par ordre alphabétique Trier par contribution nette de l'UE Tout développer Tout réduire Tiers Entité juridique autre qu’un sous-traitant qui est affiliée ou juridiquement liée à un participant. L’entité réalise des travaux dans les conditions prévues par la convention de subvention, fournit des biens ou des services pour l’action, mais n’a pas signé la convention de subvention. Le tiers respecte les règles applicables au participant qui lui est lié dans le cadre de la convention de subvention en ce qui concerne l’éligibilité des coûts et le contrôle des dépenses. FIRALIS France Contribution nette de l'UE € 804 354,50 Adresse RUE DU FORT 35 68330 Huningue Voir sur la carte PME L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention. Oui Région Grand Est Alsace Haut-Rhin Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Liens Contacter l’organisation Opens in new window Site web Opens in new window Participation aux programmes de R&I de l'UE Opens in new window Réseau de collaboration HORIZON Opens in new window Coût total € 804 354,50
