DECODE reDucing the health and Economic COst of Diagnostic uncErtainty: establishing potential applications of BV™ and its composite biomarkers in COVID-19 detection and patient management

Problem: Clinicians routinely face diagnostic uncertainty because acute infections are often clinically indistinguishable and today's diagnostics have constraints. This uncertainty leads to inappropriate patient management, including antimicrobial misuse and avoidable hospitalization. The associated health economic burden are inferior patient outcomes, elevated costs, and antimicrobial resistance (AMR), one of the top 10 threats to global health. Potential solution: In many instances, the clinician only needs to know with confidence if the infection is bacterial or viral to decide how to manage a patient suspected to have an acute infection. We have developed and validated MeMed BV™ - a pioneering test for distinguishing between bacterial and viral infections that decodes the body's immune response to infection. BV™ has been both double-blind and externally validated in clinical studies enrolling thousands of patients and demonstrated superiority to biomarkers in routine use. Concurrently, we have developed Key™, an easy-to-use POC platform that runs BV™ in 15 minutes. To establish potential applications of BV™ and its composite biomarkers in managing COVID-19 patients, the following objectives are proposed: 1. To deploy BV™/Key™ at hospitals in Israel, Germany and Italy that are managing COVID-19 patients. 2. To collect real world evidence to support the performance of BV™ in identifying early viral infection and predicting/monitoring disease severity of COVID-19 disease. 3. To mature the BV™/Key™ system based on lessons learned during deployment. Impact: Fulfilment of Objectives 1 and 2 will pave the way to full EU commercialization of the BV™ biomarkers as an aid in COVD-19 patient management. Obtainment of Objective 3 will mature the BV™/Key™ system in readiness for a wider launch to support the fight against COVID-19. Taken together, the efforts of this project will take BV™ on Key™ from a regulatory cleared test to one that is available commercially and adopted in routine care and is ready for broader launch. By providing an actionable tool that reduces diagnostic uncertainty, this project will improve patient outcomes while reducing healthcare costs and help fight AMR.