LONDON – After eight years in development, Memed Diagnostics Ltd. has secured CE marking for its point-of-care blood test, which is able to distinguish between bacterial and viral infections in 15 minutes.

The approval opens the way for commercial roll out of the Memed-BV diagnostic and for the underlying technology Memed Key to form the basis of further blood biomarker diagnostics, to be developed in house and by licensing partners.

While most infectious disease diagnostics look for the pathogen, Memed assesses host immune response to infection, measuring the levels of immune system proteins and applying proprietary algorithms to generate an immune signature.

Memed-BV measures TNF-related apoptosis inducing ligand (TRAIL), interferon gamma-induced protein and C-reactive protein. When factored together, these three items show if an infection is caused by a virus or bacteria. That looks like “a simple question” but takes a significant amount of time to answer using current methods, noted Eran Eden, Memed cofounder and CEO of the Haifa, Israel-based company.

As a result, the tendency is for patients with acute infections to be treated with broad spectrum antibiotics. Getting more appropriate treatment sooner will improve outcomes, lower health care costs and reduce the spread of antibiotic resistant infections, Eden said. “The purpose is to use Memed-BV in different clinical settings to make better use of antibiotics,” he told BioWorld.

In total, Memed-BV has been validated with data from more than 15,000 patients, and has shown more than 90% sensitivity and specificity across multiple pathogens.

Following CE approval, the Memed-BV commercial test will first be made available to clinical centers in Europe and Israel that collaborated in the development of the diagnostic, allowing the company time to build up supply chains and scale up manufacturing. “They have been running clinical studies to support generation of the clinical evidence required, and will get early access,” said Eden.

The diagnostic is an “essential step” in the fight against antimicrobial resistance, said Louis Bont of the division of pediatric immunology and infectious disease at the University Medical Center in Utrecht, Netherlands, who was involved in an international double-blind study of Memed-BV. This and other trials show the approach of measuring host response, “enables more accurate diagnoses compared to today’s routine tests,” Bont said. “It will meaningfully aid clinicians in improving antibiotic treatment decisions.”

With estimates that of 40 million antibiotic prescriptions annually for respiratory tract infections in the U.S., 23 million are unnecessary, the ability to quickly exclude bacteria as the cause at the point of care could be an important lever in reducing inappropriate prescribing and slowing the development of antimicrobial resistance.

Most immediately, Eden foresees Memed-BV being used to test patients presenting in emergency departments with suspected lower respiratory tract infections and in children who appear to have a serious infection for which the source is not clear.

“Eventually it will be a physician’s office test,” Eden said. That would enable doctors to resist patient requests for antibiotics to treat each respiratory tract infection, potentially making a huge contribution to reducing development of antimicrobial resistance. In the U.K. for example, 46% of primary care prescriptions for antibiotics are for respiratory tract and ear, nose and throat problems. Most of these drugs have no effect, because fewer than 10% of respiratory tract infections seen by general practitioners are caused by bacteria.

It took Memed four years to get to the point of having a reliable bacteria/virus immune signature and another four years to develop the point-of-care instrument for carrying out the analysis.

Now that it is CE approved, the instrument provides the platform to develop other tests. Memed is working on a diagnostic for stratifying COVID-19 patients according to the likely severity of immune response they will experience, and to monitor response to immunomodulatory drugs that are being repurposed as therapies for severe immune reactions.

The company also is developing a bedside test for sepsis and is running U.S. trials to get FDA clearance for its technology.

In parallel, Memed is in licensing discussions with companies operating large centralized labs that want to diversify, and startups with novel biomarkers.

Kfir Oved, Memed cofounder and chief technology officer, said Memed Key makes it possible to conduct highly sensitive, rapid, multiplexed protein measurements at the point of care that previously could only be done on expensive central lab equipment. “The Memed Key platform will allow us to expand our host response test pipeline to other indications outside infectious diseases,” he said. “We are now expanding our partnerships to make these technologies widely available.”