New Study Demonstrates Superiority of MeMed's ImmunoXpert™ Over Procalcitonin, CRP, HNL and Additional Biomarkers in Distinguishing Bacterial From Viral Infections

TIRAT CARMEL, Israel, May 15, 2018 /PRNewswire/ -- MeMed today announced publication of a large study that compared the diagnostic performance of MeMed's novel blood test, ImmunoXpert™, to routinely-used as well as candidate biomarkers and clinical prediction rules. The head-to-head study was led by a team of researchers from Schneider Children's Medical Center, under the supervision of Prof. Shai Ashkenazi, Chair of the Israeli Pediatric Association. The results were published in the online version of European Journal of Clinical Microbiology & Infectious Diseases. ImmunoXpert™ test aims to support clinicians in one of the most routine yet challenging clinical dilemmas today – determining whether an infection is bacterial or viral – to decide whether to treat, or not to treat, with antibiotics.

"One of the main challenges when evaluating new biomarkers is the lack of head-to-head comparison data, as each diagnostic test is assessed in a different study, performed on different patients and using different comparator methods," said Prof. Shai Ashkenazi, MD, the Director of the Pediatrics Department A at Schneider Children's for the past two decades. "In this study we evaluated, for the first time, a wide range of candidate tests for differentiating between bacterial and viral infections, using the same group of patients and a unified reference standard procedure, focusing on two prevalent clinical syndromes that are very difficult to diagnose as bacterial or viral."

The comparison study employed specimens collected prospectively at two secondary medical centers from 314 children and adults with respiratory infection and fever without source. ImmunoXpert™ accurately distinguished between bacterial and viral patients with 93.5% sensitivity and 94.3% specificity, and a negative predictive value of 95%. The test outperformed routinely used biomarkers including procalcitonin, C-reactive protein, as well as candidate biomarkers such as IL-6 and human neutrophil lipocalin (HNL/NGAL). The test was also more accurate than standard laboratory parameters used to manage patients with infections, including white blood count, absolute neutrophil count, and performed better than multiple prediction rules, including the Lab Score. The test correctly identified as viral 50 of 57 viral patients prescribed antibiotics, suggesting potential to reduce antibiotic overuse by 88%.

"We evaluated some of the more common biomarkers as well as candidate biomarkers and prediction rules," commented Dr. Oded Scheuerman, one of the leading researchers. "Applying strictly pre-defined cut-offs and a unified comparator method allowed us to identify the best performing test."

Dr. Liat Ashkenazi-Hoffnung, a co-lead researcher, added, "Rapid and actionable diagnostic tools can help physicians make better informed antibiotic treatment decisions. The demonstrated potential to reduce unwarranted antibiotic prescription by almost 90% is a key finding."

"This study represents another important milestone in the journey that a novel test undergoes towards clinical adoption," said Kfir Oved, PhD, MeMed CTO. "In parallel to clinical validation, we are finishing work on an easy to use point-of-care platform, with support from the US Department of Defense, to provide results within minutes, where and when it is most needed."

About MeMed

MeMed is dedicated to improving patient care through research, development and commercialization of solutions that decode the immune system's distinct responses to different health and disease states. The company focuses on providing rapid, accurate and actionable tests for acute infectious diseases and inflammatory disorders to be used in the hospital and community. Its first-generation test, ImmunoXpert™, measures three blood borne immune markers to accurately detect whether a patient has a bacterial or viral infection, with the aim of empowering physicians to make more informed antibiotic treatment decisions. ImmunoXpert™ is cleared for clinical use in the EU (CE-IVD certified), Switzerland and Israel. It is currently in pilot distribution in these territories with a broader commercial roll-out underway. MeMed's second-generation test will provide rapid (within minutes) results at the point-of-care. The company is partnering with international stakeholders from industry and government to facilitate global availability of its tests. For additional information, please visit http://www.me-med.com.

Company Contact:

Tanya Gottlieb
VP Scientific Affairs, MeMed
Phone:  +972-4-8500302
[email protected]

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Kirsten Thomas
The Ruth Group 
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