Description du projet
Un test rapide pour différentier les infections bactériennes des infections virales
Dans les cas d’infections graves, il est souvent difficile de différentier les causes, à savoir bactérienne ou virale. Cela empêche les médecins de poser des diagnostics adaptés et leur fait prendre des décisions coûteuses concernant l’hospitalisation ou le traitement médical du patient. En outre, des dépenses inutiles et le développement d’une résistance antimicrobienne (RAM) sont les conséquences directes de la difficulté de diagnostic. Le projet DECODE financé par l’UE va commercialiser un test innovant mis au point par la société MeMed, appelé MeMed BV™, ainsi qu’une plateforme polyvalente simple dernier cri appelée MeMed Key™, afin de piloter des immuno-essais diagnostiques quantitatifs pour la différentiation des infections bactériennes et virales. Ces outils sont rendus possible par l’utilisation de l’apprentissage automatique et de la technologie de détection précise via chimiluminescence, afin de décoder les signaux émis par le système immunitaire. Le projet DECODE permettra également de réduire les coûts et les problèmes des patients résultant de l’incertitude diagnostique.
Objectif
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.
Champ scientifique
Programme(s)
Régime de financement
SME-2 - SME instrument phase 2Coordinateur
39120 TIRAT CARMEL
Israël
L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.