Objective 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. Fields of science engineering and technologymechanical engineeringmanufacturing engineeringnatural sciencesbiological sciencesbiochemistrybiomoleculesnucleic acidsmedical and health scienceshealth sciencesinfectious diseasesengineering and technologymedical engineeringmedical laboratory technologymedical and health sciencesbasic medicinepharmacology and pharmacy 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 SELFDIAGNOSTICS DEUTSCHLAND GMBH Net EU contribution € 3 575 024,03 Address Deutscher platz 5 d 04103 Leipzig 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 Sachsen Leipzig Leipzig 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 Other funding € 0,00 Participants (2) Sort alphabetically Sort by Net EU contribution Expand all Collapse all BIOATLAS OU Estonia Net EU contribution € 951 299,97 Address Riia 181 a 51014 Tartu 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 Eesti Eesti Lõuna-Eesti 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 Other funding € 0,00 Recon A/S Participation ended Denmark Net EU contribution € 0,00 Address Tinggardvej 1 6400 Sonderborg See on map Region Danmark Syddanmark Sydjylland 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 Other funding € 0,00
