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First-of-it’s-kind: Israeli-developed blood test to diagnose bacterial and viral infections receives FDA approval

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MeMed’s BV blood test decodes the body’s immune response to infection and will assist with cutting down on the overuse of antibiotics

By ILANIT CHERNICK

In a groundbreaking success, the US Food and Drug Administration has approved a “pioneering blood test” developed by Israeli MedTech firm MeMed.

According to MeMed, the BV test helps “physicians with the seemingly simple clinical dilemma – does a patient have a bacterial or viral infection,” and will assist with cutting down on overuse of antibiotics.

“The novelty of MeMed’s technology is that it decodes the body’s immune response to infection, the ‘host response’, rather than focusing on detecting the presence of a microbe,” the MedTech firm explained. “This allows robust diagnosis when the infection site is inaccessible or unknown, even when the pathogen is undetectable using conventional tests, or when the cause of infection is emerging new pathogens.”
The MeMed BV blood test “enables better informed antibiotic treatment decisions, an essential tool in the fight against resistant bacteria.”

Reacting to this exciting news, Dr Eran Eden, MeMed’s co-founder and CEO explained that “it has been a decade-long journey to reach this point from concept to impacting patient lives.”

“This FDA clearance is a breakthrough moment in the field of advanced host-response and could not have been achieved without the dedication of the MeMed team, our clinical partners in the US and around the globe, and the support of the US Department of Defense and EU Commission,” he said.

In July, the MeMed BV blood test received the prestigious European CE mark as well, meaning that the test has approval to be used in Europe as well.
At the time, Eden said that “at its core, MeMed is about decoding the signals of the host-immune response to help physicians make better-informed decisions that improve patients’ lives.” 

“The CE-IVD mark brings us closer to impacting patients around the globe. We believe MeMed BV…will be a major addition to the clinical arsenal, improving outcomes for patients with acute infections, lowering healthcare costs and combating antibiotic resistance,” he said.

Following its FDA approval, Sergey Motov, professor of emergency medicine at Maimonides Medical Center in New York City, said that “host-response technologies,” which the blood test is based on, “are a new frontier in the management of adults with infectious diseases, with great potential to improve patient outcomes.”
He emphasized that “every day, I see patients with a complicated medical history presenting to the emergency room with a suspected respiratory tract infection. 

A technology like MeMed BV can significantly aid in their management,” Motov said.

Adding to this, Prof. Rich Bachur, who is a professor of pediatrics and emergency medicine at Harvard Medical School said that “this novel test offers promise to help differentiate those children with self-limited viral illness from those with possible bacterial infection, thereby supporting the judicious use of antibiotics.”

Back at home in Israel,  Dr Adi Klein, director of the Pediatric Division at Hillel Yaffe Medical Center and head of the Israeli Clinical Pediatric Society, who has been using the MeMed BV test in her department said it is making a major difference when diagnosing bacterial or viral infections.

“For example, we recently had a complicated case of a young child with fever but without a clear source. 

“MeMed BV helped in the early identification of a severe bacterial infection, that would otherwise be masked by viral PCR detection, lead to a change in the course of treatment, and made a big difference in the patient’s outcome,” she concluded.

MeMed is a portfolio company of OurCrowd.

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