PoC-CycleProject ID: 652303
Financé au titre de:
H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being
Innovative Molecular Diagnostics point-of-care device for MRSA
Détails concernant le projet
Coût total:EUR 71 429
Contribution de l'UE:EUR 50 000
Sujet(s):PHC-12-2014-1 - Clinical research for the validation of biomarkers and/or diagnostic medical devices
Appel à propositions:H2020-SMEINST-1-2014See other projects for this call
Régime de financement:SME-1 - SME instrument phase 1
FRIZ has developed PoC-Cycle® platform- an innovative diagnostics device introducing efficient multiplex nucleic acid testing to the point-of-care. It provides a combination of accuracy and sensitivity, multiplexing, and optimized workflow from sample collection to diagnosis. Current diagnostics platforms are technically limited: On one side only few sequence signatures can be checked, on the other side, the analysis of these signatures are mostly considered in one sequence area only due to the high complexity in developing Multiplex-PCR, as well as missing process-robustness for routine administration. FRIZ implemented a multiplex analysis in disposable microfluidic cartridge format with integrated semiconductor based on microarrays for the rapid and sensitive detection of a broad range and number of biomarkers.
Key market is the screening of MRSA, a pathogen with wide spread and growing negative impact to European patients and health care systems. Experts forecast the number of deaths will increase from 6,000 to approx. 17,000 in 2015. Main users of the device are hospitals as they require simple and safe handling as well as fast and reliable results. European market potential can be estimated with 900,000 tests per year resulting in a yearly turnover of almost two million €. The new diagnostic device will significantly reduce the number of infections. Moreover, it provides future business opportunities due to its general approach for diagnose further pathogens e.g. HPV or tuberculosis.
Within the project, FRIZ aims to identify end-users for validation, discuss the handling and identify possible variations to enhance the usability and acceptance of the new system in phase 2. To find an appropriate partner for validation is also part of this feasibility study. In addition, FRIZ prepares a revised version of a “freedom-to-operate” analysis. A multicentric validation study is planned as well as interviewing end-users and built up a pilot production in phase 2.
Contribution de l'UE: EUR 50 000