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).
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 a new immune-based diagnostics called 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.
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).
As part of the project, ImmunoXpert™ manual ELISA test is transitioned onto Freedom EVO® 75 (Tecan), a state of the art compact pipetting robot that will reduce hands-on technician time, increasing clinical utility and potential health economic benefit.
Pilot Adoption & Clinical Utility
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.
The pilot includes three main activities: (i) performance analysis of ImmunoXpert™ in distinguishing between patients with bacterial and viral etiologies; (ii) clinical utility evaluation based on questionnaires to be completed by participating physicians; and (iii) health economics evaluation by comparing data collected during the pilot with historical data.
During the pilot, the ImmunoXpert™ assay is being performed on site using the automated Freedom EVO® 75 platform.