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.
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