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FDA Clears Technology to Distinguish between Bacterial and Viral Infections

FDA grants 510(k) clearance for use of the MeMed BV® test to help distinguish between bacterial and viral infections


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Published:Sep 24, 2021
|3 min read

HAIFA, ISRAEL, BOSTON, MA — MeMed, a leader in the emerging field of advanced host-response technologies, announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for use of the MeMed BV® test on the point-of-need platform MeMed Key® to help healthcare providers distinguish between bacterial and viral infections. The technology has been cleared for both children and adults.

Bacterial and viral infections are often clinically indistinguishable, leading to the prescription of antibiotics for the treatment of viral infections, for which they are ineffective. Antibiotic misuse drives the emergence of antimicrobial resistance (AMR), one of the biggest healthcare challenges of our time.

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. 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 are emerging new pathogens. It enables better informed antibiotic treatment decisions, an essential tool in the fight against resistant bacteria. 

“For those of us who care for acutely ill children, we have been waiting decades for accurate, rapid diagnostics to confidently guide the care of moderately ill children without a clear focus of infection or recognizable viral illness. 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,” said Rich Bachur, MD, professor of pediatrics and emergency medicine, Harvard Medical School, and chief, Division of Emergency Medicine, Boston Children's Hospital.

“It has been a decade-long journey to reach this point from concept to impacting patient lives,” said Dr. Eran Eden, MeMed’s co-founder and CEO. “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.”

Sergey Motov, MD, professor of emergency medicine, Maimonides Medical Center, New York, said: “Host-response technologies are a new frontier in the management of patients with infectious diseases, with great potential to improve patient outcomes. Every day, I see adults 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.”

“We are now using MeMed BV in my department routinely to aid in determining whether a child with fever has a bacterial or viral infection. For example, we recently had a complicated case of a young child with fever but without a clear source. MeMed BV helped in 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,” said Dr. Adi Klein, director of the pediatric division, Hillel Yaffe Medical Center and head of the Israeli Clinical Pediatric Society. “Introducing MeMed’s technology has had a significant impact on our medical practice, enabling us to be better stewards of antibiotics and improving patient outcomes.” 

FDA clearance was based on a multi-center blinded clinical validation study enrolling over 1,000 children and adults and addresses goals laid out in the US National Action Plan for Combating Antibiotic Resistant Bacteria. The test provides highly accurate results with Area Under the Curve of 90 percent and 97 percent (primary and secondary endpoints). MeMed has established its US base in Boston and is ramping up commercial activities to ensure broad availability of its products across the US.

- This press release was originally published on the MeMed website