Test aiming to provide better treatment decisions receives CE mark

MeMed, has received a CE mark in Europe for use of its diagnostic test MeMed BV and point-of-need platform MeMed Key.

Eran Eden, MeMed’s co-founder and CEO, said: “At its core, MeMed is about decoding the signals of the host-immune response to help physicians make better informed decisions that improve patients’ lives. The CE-IVD mark brings us closer to impacting patients around the globe. We believe MeMed BV and MeMed Key will be a major addition to the clinical arsenal, improving outcomes for patients with acute infections, lowering healthcare costs and combating antibiotic resistance. We are indebted to the United States Department of Defence and the European Commission for their continuous support, helping us reach this significant milestone, as well as to our research collaborators who are generating an unprecedented amount of clinical evidence in the US, Europe and other regions around the globe.”

MeMed BV measures host-immune response proteins from a small sample of blood and applies machine learning in order to distinguish between bacterial and viral infections. This provides information aimed to better inform antibiotic and antiviral treatment decisions. MeMed BV has been validated by real-world data from over 15,000 patients and multinational, double-blind clinical studies, published in peer-reviewed journals, showing over 90% sensitivity and specificity (NPV>98%) across multiple pathogens.

MeMed Key is a platform that allows measurements of multiple proteins at the point of need, and specifically it runs MeMed BV within 15 minutes.  

Professor Louis Bont, division of paediatric immunology and infectious disease, University Medical Center, Utrecht, said: “While traditional diagnostics focus on identifying the disease-causing viruses or bacteria, this technology works differently. It identifies whether the patient’s immune system is actively fighting a bacterial or viral infection. Our international, double-blind study conducted and published in Lancet ID and BMJPaediatrics, as well as studies by others, showed that this host-response solution enables more accurate diagnoses compared to today’s routine tests and will meaningfully aid clinicians in improving antibiotic treatment decisions. This diagnostic is an essential step in our collaborative fight against antimicrobial resistance."