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Israel Medical Tech Company Gets FDA approval for "Breakthrough" Infection Test

MeMed diagnostics, a Haifa-based medical technology company, announced Monday that their "breakthrough" diagnostic infections test received FDA approval. MeMed BV, a blood test that distinguishes whether an infection is caused by bacteria or a virus, is now cleared for use on adults and children.

"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," Dr. Eran Eden, CEO and co-founder of MeMed, said. Eden called the technology a "breakthrough moment."

It's often impossible for a health care provider to tell the difference between a viral and bacterial infection. A patient can have the sniffles and a cough with either. This has led to an overprescribing of antibiotics (which only works on bacteria, not viruses), which has created "superbugs" that are resistant to treatment.

AMR (antimicrobial resistance) is one of the top ten global public health threats, according to the World Health Organization.

"Often bacterial and viral infections can be clinically indistinguishable, and there's lots of uncertainty, and this uncertainty leads to overuse of antibiotics. And that, in turn, leads to antimicrobial resistance, one of the biggest health care challenges of our time," Eden said. "Without antibiotics, you basically lose modern medicine."

Now that the FDA hurdle has been cleared, the MeMed test will be available to hospitals, emergency rooms, and urgent care facilities. Eden says that the test will provide vital support. To help medical staff in their treatment of anyone with a suspected acute infection from respiratory to urinary tract to systemic. Eden said it will "tell the physician whether the body is waging war on bacteria or on a virus…whether to treat with antibiotics or, practically, chicken soup."

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