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Homs, Antoni - TheraEDGE: An integrated platform enabling theranostic applications at the point of Primary Care
 

Homs, Antoni - TheraEDGE: An integrated platform enabling theranostic applications at the point of Primary Care

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INNOVATION CAPSULES: Track 2: Tecnologías para la transformación del sistema sanitario

INNOVATION CAPSULES: Track 2: Tecnologías para la transformación del sistema sanitario

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    Homs, Antoni - TheraEDGE: An integrated platform enabling theranostic applications at the point of Primary Care Homs, Antoni - TheraEDGE: An integrated platform enabling theranostic applications at the point of Primary Care Presentation Transcript

    • An Integrated Platform Enabling Theranostic Applications at the Point of Primary Care • Industry-driven project to accelerate the adoption “Antimicrobial resistance – also known as drug resistance – occurs when microorganisms of theranostic applications in Primary Care. such as bacteria, viruses, fungi and parasites change in ways that render the medications used to cure the infections they cause ineffective … • Built around the high-incidence clinical case of This is a major concern because a resistant infection may kill, can spread to others, and early-diagnosing lower respiratory tract infections. imposes huge costs to individuals and society ... Lack of government commitment to address these • Simultaneous test for different pathogens and issues, poor surveillance and a diminishing arsenal of tools to diagnose, treat and prevent also hinder their antibiotic resistance aiming to enhanced the control of drug resistance.” clinical outcomes, improved patient healthcare World Health Day 2011 key health issue, World Health Organization (WHO) and reduced costs. INFORMATION & COMMUNICATION TECHNOLOGIES EU SEVENTH FRAMEWORKContact: fguasch@biokit.com Contact: ahoms@ibecbarcelona.eu PROGRAMME
    • Objective  Improve treatment efficiency and reduce current pathogens antibiotic resistance growth by eliminating diagnostic uncertainties and pointing out the correct specific treatment.  Achieve a faster clinical turnaround by enabling clinical decision-making in less than 30 minutes from sample extraction to result delivery.  Improve analytical performance by employing novel detection techniques with higher specificity and sensitivity than currently being used alternative POC analytical methods.  Stress usability and robustness by promoting the development of standard analytical and operational platforms.  Provide economic systems by promoting therapeutic education and compliance to generate more efficient healthcare economics. INFORMATION & COMMUNICATION TECHNOLOGIES EU SEVENTH FRAMEWORKContact: fguasch@biokit.com Contact: ahoms@ibecbarcelona.eu PROGRAMME
    • Medical System Overview TheraTEST - Analytical Platform Multiple Nucleic Acid Detection without Amplification (PCR) Disposable Cartridge based in Lab-on-Chip Technology TheraPOC - Operational Platform Universal Control Module (POC & Information Instruments) Plug & Play Semantic interoperability TheraGUIDE - Therapeutic platform Applications set build on a Convergent ITC Platform General Practitioners Support Fight antibiotic Misuse and Abuse INFORMATION & COMMUNICATION TECHNOLOGIES EU SEVENTH FRAMEWORKContact: fguasch@biokit.com Contact: ahoms@ibecbarcelona.eu PROGRAMME
    • TheraTEST: Overview  Built around the high- Result incidence clinical case of Therapy early-diagnosing in CA-LRTI. STEP 1 STEP 4  In-line to meet the usability 30 Minutes requirements defined by the CLIA-waived standards of the FDA, also applicable for the European IVD markets. STEP 2 STEP 3 INFORMATION & COMMUNICATION TECHNOLOGIES EU SEVENTH FRAMEWORKContact: fguasch@biokit.com Contact: ahoms@ibecbarcelona.eu PROGRAMME
    • TheraTEST: Analytical Protocol  Simplification of the assay into Suspension Buffer Lysis (Enz + Cntrls) few steps. NA purification Lysis Buffer Lab-on-a-Chip (LOC) technology based cartridge. Liquid Management Shear (pumping and valves) Fragmentation  No NA amplification needed. Probes Wash buffer Multiplexed assay (8 pathogens Mag. beads + Temperature Control panel) with Time to Result under Hybridization Hyb. buffer Magnetic Field 30 minutes. (Enhance  LASER-based optical detection hybridization and purification) Detection interpreted by automatic Waste Detection setup algorithms. Cartridge Envelope Instrument Interfaces INFORMATION & COMMUNICATION TECHNOLOGIES EU SEVENTH FRAMEWORKContact: fguasch@biokit.com Contact: ahoms@ibecbarcelona.eu PROGRAMME
    • TheraTEST Automated Integrated Analytical System P=P -P As Sample Preparation & NA Extraction → ( the flow).speedthe DNA approaches the difference constriction, NA Fragmentation increases and the coiled 1 2 → NA Detection & PathogenIdentification Streptococcus pneumoniae studies DNA molecules are elongated and then fragmented by drag forces when the DNA is located in the constric- 1,8 tions. The series of constrictions are used to reduce the Fluorescent 1,6 inlet outlet Detection Probe 1,4 Magnetic Bead NA concnetration (µg/ml) microchannel 1,2 1,0 0,8 DNA motion Figure 3: SEM image of a fragmentation constriction region. 0,6 0,4 Figure 4a shows optical microscopy images of com- pleted glass microfluidic chips used for DNA fragmen- 0,2 constrictions tation. The lower image shows an example a single fragmentation channel with multiple constrictions and 0,0 Lysis only on LOC With swab Without swab Figure 1: Schematic drawing of DNA fragmentation device multiple channels with constrictions. Figure 4b shows using hydrodynamic shearing forces. P= P1-P2. an example of various fragmentation chip designs. variance in the fragment length distribution. Figure 2 (a) Micrococcus luteus studies shows a top-view of a single constriction with length L 1,0 and width d, and main channel width a. The angled 0,9 constriction design reduces bubble entry into the frag- 0,8 mentation stream [11]. NA concnetration (µg/ml) 0,7 series 0,6 0,5 parallel 0,4 0,3 0,2 0,1 After collecting samples from different European hospitals, TheraEDGE is (b) 0,0 currently in pre-clinical validation phase. The different sample-preparation Lysis only on LOC With swab Without swab and detection operations have been demonstrated independently. LOC Tube Figure 2: Top-view schematic drawing of fragmentation constriction with length L and width d. Two types of device structures have been designed INFORMATION & COMMUNICATION TECHNOLOGIES and fabricated: series constrictions and parallel chan- nels. The fragmentation devices are fabricated entirely from glass (Borofloat) substrates. A single lithography EU SEVENTH FRAMEWORK Contact: fguasch@biokit.com Contact: ahoms@ibecbarcelona.eu mask is used to define the planar channel and constric- PROGRAMME tion structures and etched in the glass substrate using
    • TheraPOC & TheraGUIDEPatient GP TheraPOC Client Protocol AlarmsReminders & TheraPOC feedback Administration Clinical Interface (TCP/IP) Treatment Guidelines Follow-up TheraPOC Standard Instrument Interoperability Protocols POCT1-A2 DML (LPOCT) TheraGUIDE Standard Interoperability Protocols HL7(PDQ) IHE XDS POCT1-A2 ORI (LPOCT) eMR HIS
    • Conclusions  Turnaround times of 30 minutes seem feasible with the current simplified analytical protocol and system.  Both the instrument and cartridge prototypes are in-line to meet the usability requirements defined by the CLIA-waived standards of the FDA, which would also be applicable for the European IVD markets.  The overall system and its disposables designed and fabricated at an affordable by public healthcare systems cost.  Currently in pre-clinical verification phase; sensitivity being enhanced (currently 10pM → 1pM aimed).  The different sample-preparation and detection operations have been demonstrated independently.  It has the potential of enhancing antibiotic resistance policies and promoting tailored medicine. INFORMATION & COMMUNICATION TECHNOLOGIES EU SEVENTH FRAMEWORKContact: fguasch@biokit.com Contact: ahoms@ibecbarcelona.eu PROGRAMME
    • The Team • 4 Year Project • Budget: 11 M€ • Consortium: 16 partners • 9 Different Countries