Memed Ltd. has received a contract from the Defense Threat Reduction Agency, a branch of the U.S. Department of Defense (DoD) totaling up to $9.2 million. The contract will help fund the Tirat Carmel, Israel-based company's second generation point-of-care platform for distinguishing bacterial from viral infections.

Memed began operation in 2009 and has CE mark approval for the Immunoxpert, a first generation in vitro diagnostic blood test to determine whether a patient has either an acute bacterial or viral infection, said Eran Eden, the company's co-founder and CEO.

"When we started this journey eight years ago, we imagined this small benchtop device, that with a drop of blood and a few minutes would help a physician be able to tell a bacterial infection from a viral infection," Eden told Medical Device Daily. "That was the dream."

The second generation test will be able to be used in 15 minutes and can be used outside of medical labs, at the patient's bedside or place of treatment. It takes two hours to use the Immunoxpert.

Memed's technology addresses bacterial and viral infections that are often clinically indistinguishable, leading to antibiotic overuse and contributing to the spread of antibiotic resistance, which the World Health Organization said is approaching crisis proportions. Also the inability to rapidly differentiate infections also results in the underuse of antibiotics, estimated to occur in 20 percent to 40 percent of all bacterial infections, putting patients at risk of complications and increasing health care costs.

"This is a global problem and we need a global solution," Eden said.

Unlike most infectious disease diagnostics that rely on direct pathogen detection, Memed's assay decodes the body's immune response to accurately characterize the cause of the infection. Memed conducted research to identify three soluble proteins TRAIL, CRP and IP-10 – that are activated by bacteria or viruses. The company has developed algorithms that integrate these proteins to produce an "immune signature," a set of data that accurately identifies the cause of infection.

The collaboration with DoD opens the way to a variety of rapid multiplex-protein measurements at the point of care with lab-quality precision, which has broad applications. The project will also provide Memed the opportunity to evaluate and expand its test menu to detect early infections, even at the pre-symptomatic stage of a disease.

Memed would need to get the nod from the FDA to market the second generation test in the U.S. Eden noted it would be a while before an FDA submission.

Memed has gathered clinical data to demonstrate its first test's diagnostic prowess. Data from a study published in the March 28, 2015, edition of PLOS One showed the assay was validated in a diverse group of pediatric and adult patients at different time points after the onset of symptoms (from the first day up to 12 days) and across 56 different pathogen species. Results showed the predictive power of the assay's immune signature outperformed routine biomarker and laboratory tests.

RECENT DEVELOPMENTS IN DIAGNOSTICS

Diagnostic tests are becoming more simplistic and are able to provide outlook on a patient's condition and wide variety of diseases.

Recently, Paoli, Pa.-based Final Frontier won $2.6 million in the Qualcomm Tricorder Xprize for the creation of Dxter, an artificial intelligence-based engine that learns to diagnose medical conditions by integrating learnings from clinical emergency medicine with data analysis from actual patients.

Dxter includes a group of noninvasive sensors that are designed to collect data about vital signs, body chemistry and biological functions. This information is then synthesized in the device's diagnostic engine to make a quick and accurate assessment.

Launched in 2012, the global competition challenged teams to develop a consumer-focused, mobile integrated diagnostic device inspired by the fictional medical Tricorder of Star Trek fame.

Earlier this month, the FDA issued an emergency use authorization for Cambridge, Mass.-based, Nanobiosym Diagnostics Inc.'s Gene-Radar Zika virus test. (See Medical Device Daily, April 13, 2017.) Ultimately, the company executives said they wanted the Gene-Radar test to be a hand-held device used for sensor scanning, data analysis and recording data. Nanobiosym was quick to note it was far away from that goal, but it was getting closer each day.

Abbott Laboratories Inc. has been making waves with its diagnostic efforts. The Abbott Park, Ill.-based company recently received an FDA nod for a whole blood Zika detection test. (See Medical Device Daily, Feb. 3, 2017.) The company's Zika molecular test provides results within five to seven hours.