Lancet Infectious Diseases last week published results of an international multicenter, external double-blinded clinical study in children led by researchers from the University Medical Center in Utrecht (The Netherlands) independently confirming that ImmunoXpert, a novel blood test developed in Israel, accurately distinguishes between bacterial and viral infections in children.
ImmunoXpert, made by MeMed in Tirat Carmel, also was shown to outperform routine tests significantly.
“The results are beyond our expectations,” said principal investigator Dr. Louis J. Bont from the division of pediatric immunology and infectious disease at the Dutch medical center.
“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 CEO Eran Eden said the company “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 study,” published in March 2015 in PLOS One. “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 Dr. Kfir Oved, 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 to 60 months with lower respiratory tract infections or fever without a source. ImmunoXpert was accurate in distinguishing between clear bacterial and viral infections with a sensitivity of 88 percent, 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%.
ImmunoXpert is cleared for clinical use in the European Union, Switzerland and Israel. MeMed is collaborating on a series of multi-center clinical studies, enrolling over 10,000 patients, and has plans to conduct clinical studies in the United States in 2017. The company is partnering with international stakeholders from industry and government to facilitate global availability of its tests.