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MeMed Diagnostics, a Haifa-based company that develops diagnostic solutions to monitor the body’s immune status, has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for a test capable of distinguish between bacterial and viral infections.
The blood test, MeMed BV, has been licensed for adults and children, the company said on Monday.
Distinguishing between bacterial and viral origins in acute infections is a growing challenge for healthcare providers and can dramatically alter the trajectory of patient care.
Failure to recognize the trigger for an infection can lead to inappropriate use of antibiotics, contributing to the growing global threat posed by antimicrobial resistance (AMR), which occurs when bacteria, viruses, fungi and parasites adapt over time, making infections more difficult to treat. As a result, the proven drugs become ineffective.
The World Health Organization has declared AMR to be one of the top 10 global public health threats humanity has faced in recent years.
Dr Eran Eden, co-founder and CEO of MeMed, said the FDA clearance for his test was a “revolutionary moment in the field of advanced host response.”
“For the first time, the FDA has cleared technology that decodes the body’s immune response to accurately distinguish bacterial and viral infections within minutes,” Eden told The Times of Israel in a telephone interview Monday.
“So in a clinical scenario, let’s say you go to the doctor with your child who has a fever. Often the clinical question is whether they have a bacterial or viral infection, and are you treating it with antibiotics or not, ”Eden said.
“Often bacterial and viral infections can be clinically indistinguishable and there is a lot of uncertainty, and that uncertainty leads to overuse of antibiotics. And that, in turn, leads to antimicrobial resistance, one of the greatest health challenges of our time, ”he explained.
“Without antibiotics you are basically wasting modern medicine.”
Dr Eran Eden, co-founder and CEO of MeMed (right), seated with co-founder and CTO Dr Kfir Oved. (Courtesy: MeMed)
The purpose of the test is “to tell the doctor whether the body is waging a war against a bacteria or a virus, and simply whether to treat with antibiotics or not,” Eden added. “Antibiotics, or, practically, chicken soup.”
Eden further indicated that MeMed has been working closely with the FDA for the past five years to get the technology approved. The clearance will allow the company to now apply the technology “to children and adults for any type of suspected acute infection, whether sniffling, coughing, upper respiratory infection. or lower, urinary tract infections, systemic infection, etc. It’s very, very broad.
The test will be available in emergency departments upon admission to hospitals and emergency care centers, Eden said.
He stressed that the MeMed BV test does not “replace clinical judgment” but acts as a vital supportive tool to help physicians distinguish between infections: “Ultimately, this [test] combines with clinical judgment to make more informed decisions. It is an important piece of the puzzle.
The FDA clearance was based on a blinded multicenter clinical validation study involving more than 1,000 children and adults, the company said in the announcement. The test provides accurate results with an area under the curve (AUC, an indication that provides information about the extent of exposure to a drug and its rate of elimination from the body) of 90 percent and 97% ( primary and secondary endpoints), MeMed said.
The idea behind MeMed was first conceived over ten years ago by Eden and Dr Kfir Oved, who both studied at the Technion – Institute of Technology and did academic work together, exploring complex behaviors. of the immune system.
The MeMed Analyzer is a “point-of-need” testing device to quickly determine whether an infection is viral or bacterial. (Courtesy: MeMed)
“One of the things we immediately thought about was why not take advantage of the patient’s immune response to differentiate between bacterial and viral diseases that may be present. And in doing so, being able to fundamentally eliminate one of the most important drivers of antibiotic overuse, misdiagnosed viral infections, ”Oved told The Times of Israel.
“It’s probably the entity responsible for about 80 percent of antibiotic overuse.”
Once the problem arose, MeMed was founded in 2009. But the effects of the 2008 financial crisis were still raging and it was difficult to obtain funding.
“We started working literally in the kitchen and the garage and with our own money, with the help of friends and family, mentors and loved ones, including some of our teachers,” said told Oved.
They also funded the first clinical study and leveraged the data to start the business. Since then, “MeMed has actually done some of the largest studies on infectious disease and host responses,” he said, and has “so far measured the immune response of over 10,000 patients worldwide in controlled studies published in some of the major journals. . “
Over the past 10 years, MeMed has developed a large portfolio of intellectual property on applications related to the immune response to infectious diseases.
“This first FDA approval is the first step for us,” Oved said, indicating that additional products and tools are in the works.
The company recently received CE clearance, allowing it to market its COVID-19 severity test in Europe and the UK. The Times of Israel reported in July that the test is also expected to be given the green light for Israel, and approval discussions have also started with the FDA.
A technician processing a sample for testing with the MeMed COVID-19 severity test. (Courtesy: MeMed)
The severity test can provide an early indication of deterioration and predict subsequent progression and recovery of the disease, according to the company.
Patients deliver a tenth of a milliliter of blood, after which a nurse loads it into a cartridge and places it in 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 greater the risk of deterioration from a severe case of coronavirus. “It not only describes the severity of COVID-19 at the time of testing, but actually predicts the level of disease that will develop over the next two weeks,” Eden told The Times of Israel in July.
He said the results are 86% accurate.
MeMed has raised some $ 130 million to date from investors, including OurCrowd; Horizons Ventures; the Chinese conglomerate Ping An Group; and Israeli insurer Clal Insurance, according to the Start-Up Nation Central database. The company has offices in Haifa and Boston.
Nathan Jeffay contributed to this report.
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