Israeli medical solutions firm MeMed Diagnostics announced that it has been granted 510(k) clearance from the United States Food and Drug Administration (FDA) for a test that can distinguish between bacterial and viral infections.
The test, named the MeMed BV, has been cleared for both children and adults, the company said on Monday.
Bacterial and viral infections are often clinically indistinguishable, leading to the prescription of antibiotics that are ineffective because the doctor thinks the patient has a bacterial infection when it’s actually viral. Antibiotic misuse drives the emergence of antimicrobial resistance (AMR), which is considered one of the biggest healthcare challenges of our time.
The Haifa-based company says its technology decodes the body’s immune response to infection, the “host response,” rather than focusing on detecting the presence of the microbe. The test “demonstrates robust performance even when the infection site is inaccessible, or the cause of infection are emerging new pathogens,” the company said. This enables better informed antibiotic treatment decisions, an essential tool in the fight against resistant bacteria.
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 broadly availability of its products across the US, the company said.
“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.”
“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 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,” said Sergey Motov, MD, Professor of Emergency Medicine, Maimonides Medical Center.
“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 big difference in the patient’s outcome,” said Dr. Adi Klein, Director of 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.”