
MeMed Gets BARDA Contract for Novel Test to Differentiate Bacterial and Viral Infections
MeMed has secured a contract valued at $727,799 from the Division of Research, Innovation, and Ventures (DRIVe) under the U.S. Department of Health and Human Services, specifically the Biomedical Advanced Research and Development Authority (BARDA). The contract will play a role in supporting the implementation of a randomized controlled trial designed to enhance the clinical utility data associated with MeMed BV test.
The MeMed BV test represents an FDA-cleared diagnostic tool that relies on host response-based technology. In a 15-minute window, the test can accurately differentiate between bacterial and viral infections, making it suitable for application in various healthcare settings. The primary purpose of MeMed BV is to facilitate the appropriate use of antibiotics, thus contributing to the global fight against antibiotic resistance, a formidable challenge to public health.
The test has been clinically validated in real world settings. A recent study published in the Lancet medical journal demonstrated the ability of the test to differentiate pathogen type in pediatric patients with respiratory infections. The study, conducted between October 2013 and March 2015, included 577 children aged 2 to 60 months. A panel of three experienced pediatricians adjudicated the reference standard diagnosis for each patient, determining whether they had a bacterial or viral infection. The panel considered all available clinical and laboratory data, including a 28-day follow-up assessment. The panel members remained masked to the assay results, and majority and unanimous diagnoses were established based on their agreement. The assay demonstrated a sensitivity of 86.7% and a specificity of 91.1% in distinguishing bacterial from viral infections. For cases with unanimous panel diagnosis, these values were 87.8% and 93.0%, respectively. The assay’s positive predictive value was 60.5%, and its negative predictive value was 97.8%. In cases with unanimous diagnosis, the positive predictive value was 62.1%, and the negative predictive value was 98.3%.
Eran Eden, CEO of MeMed, expressed the company’s unwavering commitment to establishing robust clinical evidence regarding the impact of MeMed BV on enhancing patient outcomes. The collaboration with BARDA represents a significant step towards this goal. In combination with accumulating real-world data from healthcare facilities currently employing MeMed BV, the outcomes of this clinical trial are expected to contribute substantially to the adoption of MeMed BV as a standard of care.