Abstract

An Integrated Platform Enabling Theranostic Applications at the Point of Primary Care (TheraEDGE)

Antoni Homs, SO Senior Researcher, Catalan Institute of Nanoscience and Nanotechnology (ICN2)

TheraEDGE refers to an EU industry-driven project aimed to accelerate the adoption of theranostics applications in Primary Care. TheraEDGE intends to simultaneous test for different pathogens and their antibiotic resistance resulting in enhanced clinical outcomes, improved patient healthcare and reduced costs. A commercially feasible diagnostics system, based on single use disposable LOC cartridges and their associated diagnostic device, has been prototyped. All bioassay steps have been properly integrated and tested in the final LOC achieving: 1) 76 % yield in lysis and DNA purification of M luteus; 2) 90 % yield in genomic DNA fragmentation down to average fragment lengths ~7 kbp; 3) Automated hybridization with probes and microparticles, for both single stranded DNA (ssDNA) and double stranded DNA (dsDNA); and 4) 10 pM detection limit of pre-processed M luteus DNA. Sensitivity of the system meets requirements of non-amplified samples collected with primary care protocols. Estimation of multiple pathogens analysis time is currently 40 minutes. The instrument and the cartridge have been implemented in order to meet clinical usability requirements defined by the CLIA-waived standards of the FDA. The cartridge fabrication materials, mainly COP, have been chosen to enhance performance of the final microfluidic device while facilitating its industrial fabrication.