Clinical data validate pioneering MeMed BV technology improves diagnosis of pediatric patients with fever in the Emergency Department

Clinical data validate pioneering MeMed BV technology improves diagnosis of pediatric patients with fever in the Emergency Department

• Bacterial and viral infections are often clinically indistinguishable, leading to inappropriate patient management and antibiotic misuse
• MeMed BV® is the first FDA-cleared host-immune response assay to accurately distinguish between the two in just 15 minutes

PETAH TIKVA, Israel and HAIFA, Israel; April 18, 2023 – MeMed, a leader in the emerging field of advanced host-response technologies, and Schneider Children’s Medical Center, the only comprehensive, tertiary care hospital of its kind in Israel, today announce that clinical data from the independent, prospective Rosetta study, recently published in PLOS One, showed that the MeMed BV test provides an accurate diagnosis of bacterial versus viral infection and reduces Emergency Department (ED) physician error.

The Rosetta study paper is called: Bacterial vs viral etiology of fever: A prospective study of host score for supporting etiologic accuracy of emergency department physicians.

Fever is a common symptom in children presenting to the ED and owing to limitations of real-time decision-making, attending physicians often make presumptive diagnoses. This diagnostic uncertainty can result in sub-optimal patient management, including the precautionary use of antibiotics [1,2]. There is an urgent need for a rapid and accurate test that can assist physicians in distinguishing between bacterial and viral infections, enabling improved diagnosis and reducing the incidence of unnecessary antibiotic prescriptions.

To address the unmet need, MeMed developed the world’s first US FDA-cleared advanced host-response technology that differentiates between bacterial and viral infection in 15 minutes – the MeMed BV test.

The Rosetta study assessed the potential of MeMed BV to impact decision making and antibiotic stewardship in the ED by comparing its performance to physician’s etiological suspicion at patient presentation. The study enrolled 287 participants aged 3 months to 18 years, with respiratory tract infection or fever without source, in a tertiary care pediatric ED.

MeMed BV showed high diagnostic accuracy, with an area under the curve (AUC) of 96%, sensitivity of 89%, specificity of 92%, and negative predictive value (NPV) of 99%. Furthermore, comparing physician suspicion to MeMed BV and to the reference standard, and assuming full adoption, the study found that MeMed BV has the potential to improve physician diagnosis and reduce errors by around two-fold, from 16% to 8%.

Meirav Mor MD, Head of Hospital Infection Control and Senior ED Physician at Schneider Children’s Medical Center, commented: “At Schneider, we’re dedicated to providing world-class pediatric care. In the Rosetta study, we assessed the impact of incorporating MeMed BV alongside our standard of care for children and discovered its significant potential for enhancing patient outcomes while also addressing the global antimicrobial resistance crisis.”

Dr. Eran Eden, MeMed’s CEO and co-founder, added: “We’re delighted to present the latest findings from the Rosetta study, focused on pediatric patients that present to the emergency room with fever without a source or respiratory tract infections. The study adds to a growing body of evidence that underscores MeMed BV’s reliability across diverse populations. This outcome serves as a testament to our unwavering commitment – to delivering tremendous clinical results, and we eagerly anticipate publishing additional in due course, exploring the use of MeMed BV in different patient populations.”