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  • Periodic Reporting for period 1 - DIAGORAS (Chair/bedside diagnosis of oral and respiratory tract infections, and identification of antibiotic resistances for personalised monitoring and treatment)

DIAGORAS Report Summary

Project ID: 633780
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - DIAGORAS (Chair/bedside diagnosis of oral and respiratory tract infections, and identification of antibiotic resistances for personalised monitoring and treatment)

Reporting period: 2015-06-01 to 2016-11-30

Summary of the context and overall objectives of the project

What is the problem/issue being addressed:
According to the World Health Organization (WHO), antibiotic resistance already causes an estimated 700,000 deaths annually and – without effective action – is predicted to cause 10 million deaths annually by 2050. Additionally, respiratory tract infections (RTIs) are among the top reasons for visiting a general practitioner, and one of the major causes associated with the unnecessary prescription of antibiotics.
Oral infections – periodontitis and caries – are the most prevalent chronic diseases with more than 5 billion cases worldwide, deteriorating people’s quality of life and heavily burdening the healthcare systems.
Detection of the correct etiological agents (bacteria, viruses) associated with the aforementioned infections is crucial for the patient’s treatment. Unfortunately, microbial diagnosis still requires centralised diagnostic laboratories and several days to complete. This delay may lead healthcare professionals to take empirical, rather than evidence-based, treatment decisions.
The project aims to develop an innovative, more accurate, more reliable and cost effective in vitro diagnostic tool that will offer earlier disease diagnosis, patient stratification and/or prognosis, leading to improved clinical decisions and health outcomes.

Why is it important for society:
The health and social benefits as well as the market potential of the DIAGORAS chair/bedside point-of-care platform by achieving rapid, molecular-based diagnosis of RTIs, antibiotic resistances, and oral infections are enormous. The system will greatly optimise clinical treatment decision making by providing rapid and accurate diagnostic results, potentially saving billions of euros in healthcare costs.
In overview, the platform will:
• Increase the accuracy of the rapid diagnosis of infectious diseases (viral versus bacterial)
• Reduce expenditure on unnecessary and non-targeted antibiotic prescribing practices
• Help monitor the effectiveness of antimicrobial treatment continuously
• Shorten prolonged stays in hospitals caused by infectious disease complications
• Reduce the risk of nosocomial and epidemic infections by providing an effective screening tool
• Help prevent the unchecked spread of antimicrobial resistance
• Reduce the burden and costs associated with oral diseases and severe complications caused by lack of correct treatment and patient monitoring
• Decrease the overall global burden of infectious diseases, patient morbidity and mortality

What are the overall objectives:
• O.1: Better patient management, through rapid and accurate differentiation between bacterial and viral infections with similar clinical symptoms, for efficient treatment
• O.2: Prevention of antibiotic overuse based on antimicrobial resistance screening for targeted therapy
• O.3: Increased accessibility, by allowing more widespread and exhaustive epidemiological data to be gathered within hospitals, and especially in the community
• O.4: Early diagnosis and determination of the disease level
• O.5: Personalised monitoring for status control during the entire period of the oral treatment

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The progress described here refers to the 1st period of the project, namely 01.06.2015 – 30.11.2016.

WP1: Project Coordination and Management
• Achievement of: Consortium Agreement; regular Consortium Meetings; regular inter-partner communication activities

WP2: System specifications and quality control
• Set up and frequent update of: a specifications document, a risk management plan, and a quality control roadmap

WP3: Microfluidic components and integration
• Development of preliminary fluidic modules for sample preparation and amplification for nucleic acid analysis and downstream immunoassay integration in the LabDisk

WP4: DNA assay development
• Development of in-tube bead-based extraction kit for nucleic acids (both DNA and RNA)
• Design of primers and probes for the (RT)-qPCR based detection of the examined pathogens responsible for respiratory tract and oral infections

WP5: Protein assay development
• Definition of suppliers for antibodies and antigens and production of in-house antibodies, after having submitted the relevant ethical copies of authorisations
• Establishment of in-tube assays for selected periodontal-related biomarkers

WP6: Development of analysis software and reporting user interface
• Composition of design specifications, functional requirements, and high-level architecture of the IT System
• Demonstration of the server-based system

WP7: Disposable production technology and cartridge manufacturing
• Screening of plastic foil materials as candidates for the disc production
• Definition of the processing parameters of a new foil material, primarily on prototyping scale

WP8: Reader assembly and system integration
• Selection and integration of the proper hardware components, namely: motor; heating/cooling components; optical modules into first prototype to be tested at Hahn-Schickard
• Design a comprehensive software on developer mode

WP9: Clinical validation
• Preparation of the ethical documentation before patient recruitment or sample collection starts. Ethical documents have been submitted to the EC

WP10: Communication and dissemination; exploitation and translation to market
• Development of dissemination and communication plan and material
• Organisation of workshop by Hahn-Schickard during Medica 2015
• A detailed exploitation plan document has been set up, including business plan and innovation roadmap
• A market survey has been conducted, taking into account the feedback of end-users

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Healthcare impact
The project is expected to have disruptive impact on two major aspects of the healthcare practice of infectious disease diagnostics:
• Shifting the diagnostic methodology from an empirical approach (based on clinical symptoms) or traditional laboratory approach (e.g., bacterial/viral cultures) towards multiplex molecular-based analysis
• Shifting the diagnosis location from centralised laboratories and diagnostic centres towards the point-of-care at the chair/bedside via a compact, user-friendly, easy-to-interpret system.

Sustainability of the healthcare systems
The proposed DIAGORAS platform will help to improve the sustainability of healthcare systems by drastically reducing:
• the number of incorrect antibiotic prescriptions and its additional treatment costs;
• unnecessary hospitalisation and/or prolonged stays in hospitals or Emergency Rooms due to incorrect, or withdrawal of, antibiotic treatment;
• dental costs (e.g., implants) and frequent visits to dentists for treatment and monitoring;
• the time required to collect and report on infectious disease outbreaks in the community.

Economic impact
The large diversity of fields that the SME consortium partners cover can largely expand the European economic benefit and the SME activities in: (i) biomarker and assay development and diagnostic kit manufacturing (nucleic acid and immunoassay); (ii) biochemical components for assay integration and automation and extraction kits; (iii) microfluidic cartridge manufacturing with quality control systems; (iv) readout system combined with proper software for clinical data management. In addition, as the activities of the SMEs involved in the project are not restricted to a specific application field, the double application of DIAGORAS (oral infections and RTIs) broadens their market potential.

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