Objective HILYSENS II is based on the 2-year HILYSENS research and development project (started November 2010) funded by the ‘Research for the Benefit of SMEs’ program of the European Commission's Seventh Framework Programme (FP7). HILYSENS II proposes Demonstration Activities for the prototype HILYSENS Lab-on-a-Chip developed during the successful research and development project, which was designed as a specific and sensitive diagnostic system for acute, chronic and autoimmunity-associated Lyme disease. The developed prototype comprises a Bio-Chip, which enables specific and sensitive detection of the human serological responses to Borrelia species in patients with Lyme disease, and a portable Reader with user-friendly software, which together enable precise, accurate and reproducible testing of serum samples. Lyme disease is the most common tick-borne infection in Europe, with around 85,000 new cases per year. Current laboratory diagnostic methods for Borrelia species lack the necessary sensitivity and specificity to detect early cases, as well as late manifestations of the disease, such as chronic or autoimmune-related infections. As a consequence, many cases are undiagnosed or misdiagnosed. Late, delayed, or inadequate treatment can lead to serious problems, such as neuroborreliosis or arthritis, which can be disabling and difficult to treat. The HILYSENS II Demonstration Activity, which will involve SMEs from Portugal, Italy, and Spain, will include verification of the Bio-Chip and Reader components, followed by scaling-up of the production of the complete system. This will be followed by clinical validation at partner Borrelia testing centers in Germany and Sweden, and confirmatory testing in Portugal. By the end of the 24-month Demonstration Activity it is expected that the HILYSENS diagnostic system will be submitted for approval by regulatory authorities in Europe and the US and will enter these markets shortly thereafter. Fields of science natural sciencescomputer and information sciencessoftwaremedical and health sciencesclinical medicinerheumatologyengineering and technologyother engineering and technologiesmicrotechnologylab on a chip Programme(s) FP7-SME - Specific Programme "Capacities": Research for the benefit of SMEs Topic(s) SME-2013-3 - Demonstration activity Call for proposal FP7-SME-2013 See other projects for this call Funding Scheme CP - Collaborative project (generic) Coordinator STAB VIDA INVESTIGACAO E SERVICOS EM CIENCIAS BIOLOGICAS LDA EU contribution € 431 400,00 Address RUA DOS INVENTORES S/N EDIFICIO MADAN PARQUE SALAS 2.18 E 2.19 2825 182 Caparica Portugal See on map Region Continente Área Metropolitana de Lisboa Área Metropolitana de Lisboa Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Daniela Leao (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Participants (4) Sort alphabetically Sort by EU Contribution Expand all Collapse all B-C-A BORRELIOSE CENTRUM AUGSBURG BETRIEBS GMBH & CO KG Germany EU contribution € 133 200,00 Address MORELLSTRASSE 33 86199 AUGSBURG See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Armin Schwarzbach (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data MICROLIQUID SL Spain EU contribution € 296 600,00 Address AVENIDA URIBARRI 19-1 SAIOLAN 20500 ARRASATE MONDRAGON See on map Region Noreste País Vasco Gipuzkoa Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Borja Barredo (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data MICRO BIO DEVICES S.R.L Italy EU contribution € 298 200,00 Address VIA ROMA 72 86074 FILIGNANO ISERNIA See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Giovanni Ugo Altieri (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data GOETEBORGS UNIVERSITET Sweden EU contribution € 104 600,00 Address VASAPARKEN 405 30 Goeteborg See on map Region Södra Sverige Västsverige Västra Götalands län Activity type Higher or Secondary Education Establishments Administrative Contact Ellen Rydberg (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data