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

MeMed has completed development of ImmunoXpert™, an in vitro diagnostic test that leverages the body’s immune system to accurately differentiate between bacterial and viral infections. A breakthrough in infectious disease diagnosis, ImmunoXpert™ overcomes limitations of traditional diagnostics, outperforming standard of care. ImmunoXpert™ recently received regulatory European clearance (CE-IVD) and represents a close-to-market innovation. Market entry points include emergency department and hospitalized pediatric patients with respiratory tract infections (RTI) and fever without source (FWS), for which ImmunoXpert™ is uniquely positioned to improve patient management and health economics. In children, RTIs account for 50% of doctor visits and hospitalization. Fever accounts for 10-25% of pediatric ED visits, with as many as 20% without identifiable source. The global market for ImmunoXpert™ diagnosis of pediatric RTI/FWS is €2.8B (EU is €560M). To fast track market adoption across Europe we propose: •To transition ImmunoXpert™ from a hands-on laboratory assay to Tecan’s hands-free, rapid automated laboratory platform to increase clinical utility and economic benefit •To roll-out ImmunoXpert™ to EU pilot hospitals with the goal of managing 1200 pediatric patients to evaluate performance and clinical utility in real working conditions •To perform health economics analysis and establish reimbursement strategy AutoPilot-Dx is a cross sector effort (industry, KOLs, outcome researchers) highly aligned with H2020-FTIPilot’s goals and Societal Challenges: it will reduce ImmunoXpert™’s time to market and provide a road-map for sustainable market uptake; a H2020 first-time applicant is involved; the project will enable MeMed and Tecan to scale-up in line with their business strategies; the immune-based diagnostics will improve antibiotic stewardship, providing better, personalized, care for children with RTI/FWS and help fight antibiotic resistance – a global health threat.