Platform distinguishing between viral and bacterial infections cleared by FDA
MeMed, a developer of advanced host-response technologies, has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use of the MeMed BV test on the point-of-need platform MeMed Key to 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 focussing on detecting the presence of a microbe. The test demonstrates robust performance even when the infection site is inaccessible, or the cause of infection are emerging new pathogens. This enables better informed antibiotic treatment decisions, an essential tool in the fight against resistant bacteria.
Rich Bachur, MD, professor of paediatrics and emergency medicine, Harvard Medical School, and chief, Division of Emergency Medicine, Boston Children's Hospital, said: “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 recognisable 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.”
Dr Eran Eden, MeMed’s co-founder and CEO, added: “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.”
FDA clearance was based on a multi-centre 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% and 97% (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.