MeMed Diagnostics, a Haifa-based firm that develops diagnostic solutions to monitor the body’s immune state, has received United States Food and Drug Administration (FDA) 510(k) clearance for a test that is able to distinguish between bacterial and viral infections.
The blood test, MeMed BV, was cleared for adults and children, the company said on Monday.
Distinguishing between bacterial and viral origins in acute infections is a growing challenge for health care providers and may significantly alter the trajectory of patient care.
Failing to recognize the trigger of infection may lead to the inappropriate use of antibiotics, which contributes to the growing global threat posed by antimicrobial resistance (AMR). This occurs when bacteria, viruses, fungi, and parasites adapt over time, making infections more difficult to treat. As a result, proven medicines become ineffective.
The World Health Organization has declared that AMR was one of the top 10 global public health threats facing humanity in recent years.
Dr. Eran Eden, co-founder and CEO of MeMed, said that the FDA clearance for its test was a “breakthrough moment in the field of advanced host-response.”
“For the first time, the FDA cleared technology that decodes the body’s immune response in order to accurately distinguish between bacterial and viral infections within minutes,” Eden told The Times of Israel in a phone interview on Monday.
“So in a clinical scenario, let’s say you go to the doctor with your child who is sick with fever. Often the clinical question is whether they have a bacterial or viral infection, and do you treat it with antibiotics or not,” Eden said.
“Often bacterial and viral infections can be clinically indistinguishable and there’s a lot of uncertainty, and this uncertainty leads to overuse of antibiotics. And that, in turn, leads to antimicrobial resistance, one of the biggest healthcare challenges of our time,” he explained.
“Without antibiotics, you basically lose modern medicine.”
The purpose of the test is “to tell the physician whether the body is waging a war on bacteria or on a virus, and simply whether to treat with antibiotics or not,” added Eden. “Antibiotics, or, practically, chicken soup.”
Eden further indicated that MeMed has been working with the FDA very closely for the past five years to get the technology approved. The clearance is going to allow the company to now apply the technology “on both children and adults for any type of suspected acute infection, so whether its the snuffles, coughs, upper respiratory infection or lower respiratory infection, urinal tract infections, systemic infection, and so on. It’s very, very broad.”
The test will become available in emergency departments upon admission to hospitals and at urgent care centers, said Eden.
He emphasized that the MeMed BV test does not “replace clinical judgment” but acts as a critical support tool to help physicians make distinctions between infections: “At the end of the day, this [test] comes together with clinical judgment to make better-informed decisions. It’s an important piece of the puzzle.”
The FDA clearance was based on a multi-center blinded clinical validation study enrolling over 1,000 children and adults, the company said in the announcement. The test provides accurate results with Area Under the Curve (AUC, an indication that provides information on the extent of exposure to a drug and its clearance rate from the body) of 90 percent and 97% (primary and secondary endpoints), MeMed said.
The idea behind MeMed was first conceived over a decade ago by Eden and Dr. Kfir Oved, both of whom studied at the Technion – Institute of Technology and had completed academic work together, exploring complex behaviors of the immune systems.
“One of the things we immediately thought about was why not take advantage of the immune response of the patient to differentiate between bacterial and viral diseases that may be present. And by doing so, be able to basically eliminate one of the most significant drivers of antibiotics over-use, which is viral infections that are misdiagnosed,” Oved told The Times of Israel.
“This is probably the responsible entity of about 80 percent of the over-use of antibiotics.”
Once the problem was outlined, MeMed was founded in 2009. But the effects of the 2008 financial crisis were still raging, and it was difficult to get funding.
“We started working literally in the kitchen and the garage and with our own money, with some assistance from friends and family, and mentors, and people dear to us, including some of our teachers,” Oved recounted.
They also bankrolled the first clinical study and leveraged the data to start the company. Since then, “MeMed has actually performed some of the largest studies on infectious diseases and host-responses,” he indicated, and has “so far measured the immune response of over 10,000 patients worldwide in controlled studies, published in some of the leading journals.”
In the past 10 years, MeMed has developed a wide IP portfolio on applications related to the immune response to infectious disease.
“This first FDA approval is step one for us,” Oved said, indicating that additional products and tools are in the pipeline.
The company recently received CE clearance, allowing it to market its COVID-19 Severity test in Europe and the United Kingdom. The Times of Israel reported in July that the test is also expected to be greenlit for Israel, and discussions on approval have also started with the FDA.
The severity test can provide an early indication of deterioration and predict further disease progression and recovery, the company says.
Patients provide a tenth of a milliliter of blood, after which a nurse loads it into a cartridge and places it into a portable machine. Within 15 minutes the results are displayed on a screen.
The machine provides a number between 0 and 100. The higher the number, the higher the chance of deterioration due to a severe case of coronavirus. “It doesn’t just describe the severity of the COVID-19 at the moment of the test, but actually predicts what level of illness will unfold over the next two weeks,” Eden told The Times of Israel in July.
He said that results are 86% accurate.
MeMed has raised some $130 million to date from investors including OurCrowd; Horizons Ventures; Chinese holding conglomerate Ping An Group; and Israeli insurer Clal Insurance, according to the database of Start-Up Nation Central. The company has offices in Haifa and Boston.
Nathan Jeffay contributed to this report.