Periodic Reporting for period 2 - 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)
Berichtszeitraum: 2021-01-01 bis 2021-12-31
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.
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.
During this second and final reporting period, significant progress was made with respect to DECODE's three objectives:
In respect to Objective 1 – In 2021, additional Key/BV systems (CE-IVD) were deployed at medical centers in Israel and Europe. The usage was monitored using a dedicated software platform. There was a trend in increasing adoption across 2021.
To capture the full customer journey in company information systems, Enterprise Resource Program (ERP) and Customer Relationship Management (CRM) systems were implemented as well as an electronic Instructions for Use.
In respect to Objective 2 – DECODE has supported 3 types of clinical studies that have resulted in multiple publications and new findings. Importantly, these efforts have enabled the development and CE mark of a new product, called MeMed COVID-19 Severity™, which is run on MeMed Key® producing a test result from serum in 15 minutes. This new host-based tool for predicting deterioration of COVID-19 patients has great potential to facilitate timely care escalation and de-escalation, thereby improving COVID-19 patient outcomes and appropriate resource allocation.
In respect to Objective 3 – In 2021, maturation of the Key/BV system was completed and verified.
In summary, taking together the achievements of reporting periods 1 and 2, the objectives of the DECODE project have been successfully attained.
In respect to Objective 1 – In 2021, additional Key/BV systems (CE-IVD) were deployed at medical centers in Israel and Europe. The usage was monitored using a dedicated software platform. There was a trend in increasing adoption across 2021.
To capture the full customer journey in company information systems, Enterprise Resource Program (ERP) and Customer Relationship Management (CRM) systems were implemented as well as an electronic Instructions for Use.
In respect to Objective 2 – DECODE has supported 3 types of clinical studies that have resulted in multiple publications and new findings. Importantly, these efforts have enabled the development and CE mark of a new product, called MeMed COVID-19 Severity™, which is run on MeMed Key® producing a test result from serum in 15 minutes. This new host-based tool for predicting deterioration of COVID-19 patients has great potential to facilitate timely care escalation and de-escalation, thereby improving COVID-19 patient outcomes and appropriate resource allocation.
In respect to Objective 3 – In 2021, maturation of the Key/BV system was completed and verified.
In summary, taking together the achievements of reporting periods 1 and 2, the objectives of the DECODE project have been successfully attained.
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, has validated clinical utility and is ready for broader launch. In the short term, by providing physicians with an innovative and actionable tool with potential to aid in COVID-19 patient management, this project will improve patient outcomes while supporting sustainability of the healthcare system in the face of this global pandemic. In the longer term, this project has the potential to impact antibiotic stewardship and contribute to the fight against antimicrobial resistance, and more generally to ensure that infectious disease patients are better managed.