MeMed Ltd. announced today Lancet Infectious Diseases' publication of the results from OPPORTUNITY, an international multicenter, external double-blinded clinical study in children led by researchers from the University Medical Center, Utrecht. OPPORTUNITY met its primary endpoint, independently confirming that MeMed's novel blood test, ImmunoXpert accurately distinguishes between bacterial and viral infections in children. ImmunoXpert was also shown to significantly outperform routine tests.
"The results are beyond our expectations," said Professor Louis J. Bont, MD, PhD, Division of Pediatric Immunology and Infectious Disease, University Medical Center, Utrecht, the Netherlands and Principal Investigator. "We independently confirmed that the test is highly accurate in children, with significantly better diagnosis compared to any of the routine tests we use today. It has the potential to significantly aid us in reducing antibiotic overuse and combating bacterial resistance. To our knowledge, this is the first prospective validation study for a diagnostic assay differentiating between bacterial and viral infections that was double-blinded."
"MeMed took the unusual risk of allowing leading experts to independently evaluate its tests in a double-blind manner. We are excited that the new results corroborate the findings of our previous CURIOSITY study," said Eran Eden, PhD, MeMed CEO. "This is another important milestone in our continuous efforts to generate clinical evidence of the highest quality to support our tests."
"Unlike most traditional diagnostics, which focus on identifying the disease-causing virus or bacteria, ImmunoXpert looks at the immune system where it identifies markers that indicate if the patient is fighting a bacterial or viral infection," said Kfir Oved, MD, PhD, MeMed Chief Technology Officer. "This immune system-based approach overcomes the inherent limitations of many traditional diagnostic tools. It is accurate and rapid and can diagnose infections that are not readily accessible, such as pneumonia."
The study evaluated 577 children aged 2 - 60 months with lower respiratory tract infections or fever without a source. ImmunoXpert was highly accurate in distinguishing between clear bacterial and viral infections with a sensitivity of 88%, specificity of 93% and a negative predictive value of 98%. ImmunoXpert outperformed routine tests, reducing the number of cases in which viral infections were erroneously diagnosed as bacterial, by more than 50%. These findings highlight the significant potential of ImmunoXpert to aid in the reduction of unnecessary antibiotic prescriptions.
Bacterial and viral infections are often clinically indistinguishable, leading to antibiotic overuse and contributing to the spread of antibiotic resistance, which according to the World Health Organization, is approaching crisis proportions. Paradoxically, the inability to rapidly differentiate infections also results in the underuse of antibiotics, estimated to occur in 20-40% of all bacterial infections, putting patients at risk of complications and increasing healthcare costs. A test that can accurately and quickly distinguish between bacterial and viral infections has the potential to improve patient management by providing physicians with information to aid and support care decisions and reduce both the overuse and underuse of antibiotics.
MeMed continues to collaborate with clinical thought leaders on a series of large, multi-center clinical studies, enrolling over 10,000 patients, and has plans underway to conduct clinical studies in the U.S. in 2017. The company is partnering with international stakeholders from industry and government to facilitate global availability of its tests.
About MeMed MeMed is dedicated to improving patient lives through research, development and commercialization of pioneering tests that monitor the body's immune state. Its tests decode the immune system's distinct responses to different health and disease states. The company focuses on providing rapid, accurate and actionable diagnostic solutions for acute infectious diseases and inflammatory disorders in the hospital and community. Its first test, ImmunoXpert, has demonstrated the ability to accurately detect whether a patient has a bacterial or viral infection, with the aim of empowering physicians to make better informed antibiotic treatment decisions. ImmunoXpert is cleared for clinical use in the European Union, Switzerland and Israel. It is currently in pilot distribution in these territories with a broader commercial roll-out underway. MeMed's second-generation test for rapid (within minutes) point-of-care testing is under development. For additional information, please visit http://www.me-med.com.