Clinicians across the continuum of healthcare routinely face diagnostic uncertainty because acute infections are often clinically indistinguishable and today’s microbiological tools have constraints. This uncertainty leads to inappropriate patient management, including antimicrobial misuse and avoidable hospitalization. The associated health and economic burden are inferior patient outcomes and elevated costs, as well as augmentation of antimicrobial resistance, one of the top 10 threats to global health.
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. Moreover, in cases when pathogen-specific information is required, the prior knowledge of whether the infection is bacterial or viral helps to focus follow-up management. Using the immune system goes beyond state-of-the-art, as this approach addresses the constraints of pathogen-based diagnostics.
For nearly a decade, in collaboration with leading clinicians around the globe, we have developed and validated MeMed BV™ - a pioneering test for distinguishing between bacterial and viral infections that decodes body’s immune response to infection. It is based on measurements of three immune-proteins (TRAIL, IP-10 and CRP) that are computationally integrated. MeMed BV™ is the only test for distinguishing between bacterial and viral infections that has been both double-blind and externally validated in clinical studies enrolling thousands of patients and demonstrated superiority to biomarkers in routine use. Its sensitivity and specificity are over 90%. Concurrently, we have been collaborating with academic, government and commercial partners to develop Key™, a compact, easy-to-use point-of-care platform that can measure multiple proteins with central lab precision and run the BV™ test in 15 minutes. A CE mark was obtained for running MeMed BV™ on Key™ for serum samples.
To establish potential applications of BV™ and its composite biomarkers in managing COVID-19 patients, the following gaps need to be addressed:
1. Key/BV™ needs to be deployed at hospitals managing COVID-19 patients.
2. Real world evidence needs to be collected to support the performance of BV™ and its composite biomarkers in COVID-19 patient management.
3. BV™/Key™ system needs to be matured in readiness for a wider launch to support the fight against COVID-19.
Accordingly, DECODE’s objectives are:
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.
