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Demonstration Activities for the clinical validation of the prototype HILYSENS Lab-on-a-Chip

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.

Field of science

  • /social sciences/economics and business/business and management/commerce
  • /natural sciences/computer and information sciences/software

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
Address
Rua Dos Inventores S/n Edificio Madan Parque Salas 2.18 E 2.19
2825 182 Caparica
Portugal
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 431 400
Administrative Contact
Daniela Leao (Ms.)

Participants (4)

B-C-A BORRELIOSE CENTRUM AUGSBURG BETRIEBS GMBH & CO KG
Germany
EU contribution
€ 133 200
Address
Morellstrasse 33
86199 Augsburg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Armin Schwarzbach (Dr.)
MICROLIQUID SL
Spain
EU contribution
€ 296 600
Address
Avenida Uribarri 19-1 Saiolan
20500 Arrasate Mondragon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Borja Barredo (Dr.)
MICRO BIO DEVICES S.R.L
Italy
EU contribution
€ 298 200
Address
Via Roma 72
86074 Filignano Isernia
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Giovanni Ugo Altieri (Mr.)
GOETEBORGS UNIVERSITET
Sweden
EU contribution
€ 104 600
Address
Vasaparken
405 30 Goeteborg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ellen Rydberg (Dr.)