Objetivo Presented here is the proposal for the project - Homecare test device ‚intime‘ – targeting to bring the first non-instrumented nucleic acid amplification test device onto the market. Market launch will start out with a device for the diagnosis and screening of the sexually transmitted infection Chlamydia trachomatis followed by a multifunctional device including additionally Neisseria gonorrhoeae and Trichomonas vaginalis. This project is the effort of an international consortium of highly professional partners to bring the modular ‚intime’ homecare diagnostic test from a functional model to the final prototype that is ready to be produced and brought to market. SelfD Technologie will lead this consortium and provide the technology for the device, which was already developed and proven to work in a laboratory setting. Now the homecare test will undergo final prototyping with the help of renowned design company wideblue and the experienced injection molding company Recon. This prototype will then be made in a small series production for a thorough analytical and clinical validation that will allow SelfD to apply for the CE mark and introduce the product shortly after the end of the project. The production will be achieved with Recon and the prepared chemical components necessary for the assay will be provided by Bioatlas, a company that SelfD is already engaged in a strategic partnership with. The clinical trial will be executed by the CRO proinnovera and their great experience and connections will ensure a smooth collection of all relevant data. In short, the ‚intime‘ project will propel the novel diagnostic tool for home use onto the market and thus improve healthcare and allow SelfD to launch their first product and position itself as a promising IVD developer. Ámbito científico engineering and technologymechanical engineeringmanufacturing engineeringnatural sciencesbiological sciencesbiochemistrybiomoleculesnucleic acidsmedical and health scienceshealth sciencesinfectious diseasesengineering and technologymedical engineeringmedical laboratory technologymedical and health sciencesbasic medicinepharmacology and pharmacy 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 SELFDIAGNOSTICS DEUTSCHLAND GMBH Aportación neta de la UEn € 3 575 024,03 Dirección DEUTSCHER PLATZ 5 D 04103 LEIPZIG Alemania 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 Sachsen Leipzig Leipzig Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Enlaces Contactar con la organización 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 € 3 575 024,03 Participantes (2) Ordenar alfabéticamente Ordenar por aportación neta de la UE Ampliar todo Contraer todo BIOATLAS OU Estonia Aportación neta de la UEn € 951 299,97 Dirección RIIA 181 A 51014 TARTU 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 Eesti Eesti Lõuna-Eesti Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Enlaces Contactar con la organización 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 € 951 299,97 Recon A/S La participación finalizó Dinamarca Aportación neta de la UEn € 0,00 Dirección TINGGARDVEJ 1 6400 SONDERBORG Ver en el mapa Región Danmark Syddanmark Sydjylland 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 Sin datos
