DECODE SIGNED

Project "DECODE" data sheet

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 Partnership

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 Project objective

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. Gap: Broad impact of BV™ and market share require high-risk efforts to address the following major gaps: 1. Real world evidence of usage and impact on workflow. 2. Validation of clinical utility in a randomized control trial (RCT). 3. Expand applicability to primary care settings. Proposed objectives: 1. To initiate market release in DACH and gather real world data. 2. To conduct a multicentre RCT enrolling 500 children. 3. Complete development of BV™ compatible with capillary blood. Impact: DECODE will take BV™ on Key™ from a test regulatory cleared for use to one that is available commercially and adopted in routine care, has validated clinical utility and is suitable for both serum and capillary blood samples. By providing an actionable tool that reduces diagnostic uncertainty, this project will improve patient outcomes while reducing healthcare costs and help fight AMR.