Israel's MeMed company announced on Monday that it has received FDA approval for its diagnostic test and platform, which can distinguish whether an infection is viral or bacterial within 15 minutes.
The company presents its diagnostic tools as a solution for the misuse of antibiotics for viral infections, which are often indistinguishable from viruses. Beyond being an ineffective treatment, the prescription of antibiotics for non-microbial diseases contributes to antibiotic resistance, which the World Health Organization said last year is "rising to dangerously high levels in all parts of the world." A growing number of infections, the WHO said, are growing harder to treat, including pneumonia, tuberculosis and gonorrhea.
Using a blood sample, doctors can use MeMed's test to properly diagnose acute infectious diseases, such as respiratory illnesses, urinary tract infections and more. The technology, which has been cleared for both adults and children, uses the body's immune response – rather than the presence of microbes or pathogens – to classify the illness. To do so, the test measures the levels of three immune system proteins.
Dr. Kfir Oved, co-founder and chairman of MeMed's board of directors, told Haaretz: "Let's say that you bring your kid to the doctor with an acute infectious disease – with a fever, cough, rash, diarrhea, vomiting. The doctor runs tests and a verbal evaluation, and then they get stuck. In a lot of cases, the diagnosis adds up to one of two things: bacteria or a virus. The symptoms are similar, but the treatment is different.
"Now they have a tool at their disposal, whether they're in the emergency room or the doctor's office, that gives them an answer as to whether it's a viral or bacterial infection with a regular blood test, within 15 minutes. The patient gets their answer while they're still at the office, or on their way home. The results are higher quality and faster than culture or PCR tests," Oved said.
Dr. Adi Klein, the director of the pediatrics department of Hillel Yaffe Medical Center and the chairwoman of the Israel Pediatric Association, said in a press release that MeMed's test has been helpful in her work. "Just recently, we had a complicated case of a child with a fever with an unclear cause. The test succeeded in helping us identify a serious bacterial infection early on. If it weren't for the test, it would have been diagnosed as viral."
The MeMed test does have one significant limitation: It cannot differentiate between different kinds of bacterial infection. According to Oved and co-founder and CEO Dr. Eran Eden, in most cases (they say 97 percent), doctors do not need to know which bacteria is causing the infection. Even so, for patients in more serious condition, those taking medication or with a weakened immune system, knowing which kind of bacteria it is can be crucial. In these cases, the test alone is insufficient.
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Now that the company is finished developing the test and platform and has regulatory approval, MeMed's next challenge is the commercial phase. Although the company's tests are already being sold to a number of medical institutions in Europe and Israel, the company has set its sights mainly on the U.S. market. In order to sell it to them, MeMed will have to show medical suppliers and insurance companies that their product doesn't just help patients and doctors, but lower the cost of care, both in medical clinics and in cases of hospitalization.
Oved and Eden are convinced that it will. Rather than carry out a costly and time-consuming battery of tests and scans on a sick patient to determine the cause of their illness, Eden explains, they'll just need one.
The device received Israeli and European regulatory approval last year, but the FDA's decision represents a significant achievement for the company. It follows ten years of development and over $130 million in venture capital investments and contracts and grants from the European Commission and the U.S. Department of Defense.
MeMed is developing other diagnostic tests, and has already established a subsidiary in Boston with an American team, who will sell the device to hospitals and clinics.