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 a pattern recognition algorithm 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). 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, key opinion leaders, outcome researchers) aimed at driving clinical adoption of the new immune-based diagnostic: 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's far-reaching goal is to improve antibiotic stewardship, providing better care for febrile children, and help fight antibiotic resistance – a global health threat.
