A weapon against antibiotic resistance

TIRAT CARMEL, Israel—A potentially powerful tool in combating antibiotic resistance is being developed with funding from the U.S. Department of Defense (DoD). MeMed Ltd., an Israel-based diagnostic company, recently announced receipt of a $9.2-million contract from the Defense Threat Reduction Agency (DTRA), a branch of the DoD, for continued development of its platform able to distinguish bacterial infections from viral infections.

Access to a quick, reliable, and readily available diagnostic test for use in point-of-care (PoC) settings could significantly reduce antibiotic use in cases of viral infections, which are not responsive to antibiotic treatment. Such a test will also potentially offer utility in preventing epidemics and in rapid decentralized testing for various multiplex proteins.

Antibiotic overuse is largely responsible for the rapid increase in multidrug-resistant bacteria—among the biggest challenges facing healthcare today and one that places a significant burden on healthcare systems. It is estimated that more than 10 billion unnecessary antibiotics have been prescribed. In addition, more than 100 million patients are infected with antibiotic-resistant bacteria worldwide, and the cost of treating these patients is almost $230 billion.

One reason for the over-prescription of antibiotics is the difficulty in distinguishing viral infections from bacterial infections. Antibiotics are only effective against bacteria and ineffective against viral infections; however, diagnostic uncertainty leads to antibiotic misuse (overuse or underuse), resulting in an increase of drug-resistant bacterial strains.

MeMed specializes in developing and commercializing tests that monitor the body’s immune state, decoding the immune system’s distinct responses to different health and disease states. Its existing ImmunoXpert test has successfully 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. Their second-generation tool, the ImmunoPoC benchtop device, improves the technology, as it takes only 15 minutes for accurate detection and can be easily administered without needing a technician.

The tests work by measuring the patient’s own immune system to determine the nature of the illness. Using serum samples, plasma samples and whole blood, they measure proprietary immune system biomarkers coupled with pattern-recognition algorithms to accurately distinguish between bacterial and viral infections. The tools successfully complement and overcome several challenges facing current PoC diagnostic solutions, including diagnosis of inaccessible or unknown infection sites (e.g. pneumonia and fever-without-source), long time frames for results, false positives for infection due to the presence of the immune response and difficulty in test administration.

ImmunoXpert is currently cleared for clinical use and in pilot distribution in the European Union, Switzerland and Israel, with a broader commercial rollout underway. There are currently 10 studies underway testing the clinical validity and utility of the ImmunoPoC, and the U.S. Food and Drug Adminstration has begun review. With its $9.2-million contract, the DoD has joined the European Commission and several public and private partners to support and fund continued evolution of ImmunoPoC.

“We are excited by this vote of confidence. DTRA’s recognition of our work further positions MeMed as a world leader in immune-based diagnostics of infectious diseases,” said Dr. Eran Eden, MeMed’s CEO. “This joint effort, and our growing collaboration with other international stakeholders from industry and government, will facilitate the global availability of our tests aimed at combating antimicrobial resistance.”

The test has significant potential as a preventative tool, as many biomarker measurements begin to rise early in an infected person, before the onset of any noticeable symptoms. “The project will also evaluate and expand our test menu to detect early infections, even at the presymptomatic stage of a disease, currently a major challenge in our ability to control infections and epidemics,” said Dr. Tanya Gottlieb, MeMed’s vice president of scientific affairs.

In addition, the tool accurately measures any protein currently measured through large-assay lab testing. “In addition to allowing measurements of our bacterial versus viral test within minutes, the new platform also opens the way to a variety of rapid multiplex protein measurements at the point of care with lab-quality precision, which has broad applications,” according to Dr. Kfir Oved, MeMed’s chief technology officer.

“ImmunoPoC is an important part of the puzzle in identifying a systematic problem,” says Eden. “While it cannot distinguish deep characteristics or substrains of an infection—for example, whether an infection is strep A vs. strep B—it is an effective triage tool that definitively solves the bacterial vs. viral problem and empowers physicians in any setting to make critical decisions towards optimum patient care.”