Money for MeMed

TIRAT CARMEL, Israel—What if there was an easy, in-office way for doctors to reliably diagnose whether an infection was bacterial or viral? Soon there may be one—MeMed Ltd. has been working on just such a device, and after several studies the company is ready to move into manufacturing.

MeMed announced in early February that it had been awarded a $4,079,159 grant by the U.S. Department of Defense’s Congressionally Directed Medical Research Programs (CDMRP). This award will support transition of the prototype point-of-care (POC) platform towards a final product, including transfer to manufacturing and implementation of cloud connectivity.

“This grant will allow us to set up manufacturing processes for our POC platform, ultimately enabling MeMed’s novel blood test that has been clinically validated for differentiating between bacterial and viral infection to reach the patient in a shorter time,” says Dr. Kfir Oved, MeMed’s co-founder and chief technology officer.

According to Oved and company CEO Dr. Eran Eden, the company first began working on this POC platform a few years ago. “Initially, we developed a first-generation product called ImmunoXpert, based on the immune signature MeMed has developed comprising three protein biomarkers (TRAIL, IP-10 and CRP; the ‘TIC’ signature). ImmunoXpert (CE-IVD) is laboratory-based with a turnaround time of around two hours, and has been used to diagnose infections in more than 11,000 children and adults as part of our early access program, which is steadily expanding.

“Having an accurate and validated product is a must, but we knew from the get-go that it’s not enough. For global use, one needs a device that can measure the TIC signature in a very rapid, affordable and user-friendly manner,” they say. “We have been working on this next-generation product, which will provide results within 15 minutes, for the past few years, with the aim of moving into settings like hospital emergency departments and, ultimately, doctors’ offices.”

“The new device is a multi-purpose bench-top platform for quantitative immunoassays that is able to measure proteins reliably even at the picogram per mL level,” Eden and Oved tell DDNews. “In addition to measuring our rapid bacterial versus viral test, 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 application. We are already working to expand the menu of tests that will be available on the POC platform, including novel tests for predicting disease severity and for differentiating between sepsis and SIRS.”

Eden notes, “Fast menu expansion is possible, as our unique platform paves the way to performing a wide range of other multiplex-protein measurements, with laboratory quality, within minutes at the POC—the basis for a panel of tests needed to advance patient care.”

The $4-million CDMRP grant complements a $9.2-million contract from the Defense Threat Reduction Agency that MeMed was awarded last year, which is supporting the final stages of prototype development.

MeMed also recently announced completion of a trilogy of clinical studies, two of which were double-blind, conducted over the past seven years. All three trials collectively enrolled 2,376 patients. The latest study, PATHFINDER, published in the official journal of the American Academy of Pediatrics, independently confirmed that MeMed’s novel blood test accurately distinguishes between bacterial and viral infections in children. The test aims to support clinicians in one of the most routine yet challenging clinical dilemmas today—determining whether an infection is bacterial or viral, in order to decide whether to treat or not to treat with antibiotics.

According to Oved and Eden, the POC platform is “a very user-friendly device designed around many different professional and semi-professional end users, where you can basically load the sample into a cartridge, run the test from a touch screen and get the final result within minutes.”

“The company is aiming to soft launch the new POC device in select medical centers towards the end of the year. The new DoD grant will allow us to set up manufacturing processes and reach a wide range of patients in a shorter time,” Eden and Oved conclude.