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H2020

AutoPilot-Dx Report Summary

Project ID: 701088

Periodic Reporting for period 1 - AutoPilot-Dx (Fast tracking market adoption of a novel immune-based diagnostic for improving antibiotic stewardship: automation, piloting and health economics)

Reporting period: 2016-09-01 to 2017-10-31

Summary of the context and overall objectives of the project

A major driver of antibiotic misuse is the difficulty to clinically discriminate bacterial from viral infections. Antibiotic misuse leads to ineffective treatment, emergence of resistant strains of bacteria, and is estimated to cost healthcare systems worldwide tens of billions of dollars annually (Fauci and Marston, JAMA, 2014). ImmunoXpert™ is an innovative in-vitro diagnostic test that leverages the world’s most accurate diagnostic system for differentiating bacteria from viruses, crafted by nature, the body’s immune system. This test measures three proprietary blood-borne immune proteins, including a novel viral-induced protein called TRAIL, which was not previously in clinical use, and employs pattern recognition algorithms to compute viral and bacterial likelihood scores. ImmunoXpert™ was developed and clinically validated in a large-scale multicenter prospective study (`Curiosity`), enrolling over 1000 patients between 2009 and 2013 (Oved et al. 2015, Eden et al. 2016). The assay was further evaluated in a series of double-blinded external clinical studies (van Houten et al 2016, Srugo et al. 2017). ImmunoXpert™ is approved for clinical use in the EU (CE-IVD certified). AutoPilot-Dx is a European consortium funded under Horizon 2020, The EU Framework Programme for Research and Innovation under the Fast Track to Innovation Pilot. AutoPilot-Dx is a cross sector effort (industry, KOLs, outcome researchers) aimed to drive clinical adoption of the new immune-based diagnostics - ImmunoXpert™. The project outlines a trans-disciplinary approach that includes assay automation, piloting in real-world clinical settings, utility validation and health economics. AutoPilot-Dx far-reaching goal is to improve antibiotic stewardship, providing better, personalized, care for febrile children, and help fight antibiotic resistance – a global health threat.

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

During the first reporting period three main activities were performed -

1) Automation - Manual ELISA ImmunoXpert™ assay was successfully transitioned to the automated EVO 75 workstation using a dedicated script protocol. Analytical verification of automated protocol was executed according to acceptable standards. Manual ELISA and automated assays were found to be highly correlated when tested on recombinant proteins as well as on clinical samples (for both TRAIL and IP-10).

2) Piloting - The diagnostic performance and clinical utility of ImmunoXpert™ is assessed as part of the AutoPilot clinical study. The study will enroll up to 1,200 pediatric patients presenting to the ED with respiratory tract infections (RTI) and fever without source (FWS), in leading medical centers in Germany and Italy. The study is active and patient recruitment is ongoing. In the first reporting period the clinical protocol was generated and approved by the Institutional Review Boards (IRB), and over 350 patients were prospectively recruited. Medical records were formulated into eCRFs to assist in establishing the patient reference diagnosis (bacterial or viral) by a panel of three experts.

3) Health economics and reimbursement - A health economic model, associating the diagnostic pathway followed for lower respiratory tract infections (LRTI) with clinical outcomes and costs was generated. This model compares disease outcomes, costs, and patients’ quality of life in a scenario when ImmunoXpert™ is applied versus the current standard practices. An excel based interface was generated to enable model flexibility and result analysis. Additional modules that simulate the potential impact of ImmunoXpert™ test on antimicrobial resistance from different perspectives (e.g., societal, payer, hospital) are now being developed and are added to the model. A desk research in five European target countries was conducted to identify relevant the stakeholders and reimbursement processes; diagnostic and procedural codes; and the DRGs related to the reimbursement of diagnostic work and/or the treatment for respiratory tract infections.

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)

AutoPilot-Dx will result in an automated and validated diagnostic test for distinguishing between viral and bacterial infection in pediatric patients with respiratory tract infections (RTI) and fever without source (FWS). Specifically, ImmunoXpert™ will be transitioned to the robotic platform EVO 75 and its clinical utility and health economics will be established in real world settings. Successful attainment of the project’s objectives (automation, piloting and health economic analysis) will be enabled by a pan-European, multi-disciplinary team, and will drive market adoption of ImmunoXpert™ such that RTI and FWS patients receive the right treatment, at the time and place where it matters most. Fast tracking of ImmunoXpert™’s market adoption is expected to improve RTI and FWS patient outcomes (morbidity/mortality), reverse the worrying trend of increasing hospitalization, contribute to curbing antibiotic misuse (underuse and overuse), and reduce the health and economic burden of these diseases. The underlying novel premise of the proposed approach to improving antibiotic stewardship, which differentiates it from solutions that attempt to identify pathogens directly, is that ImmunoXpert™ builds on an exquisitely informative system crafted over millions of years by nature – the human immune system.

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