Sept. 20, 2021—MeMed announced FDA 510(k) clearance of the company’s MeMed BV test for use on the MeMed Key platform to help health care providers distinguish between bacterial and viral infections.
MeMed BV is an immune-based protein signature test that offers physicians a tool to help distinguish between bacterial and viral infections across multiple pathogens, even if the infection site is inaccessible or unknown. MeMed BV measures and computationally integrates the levels of three immune system proteins, TRAIL, IP-10, and CRP. The test provides a result within 15 minutes when run on the MeMed Key platform and has been cleared for children and adults.
“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,” Rich Bachur, MD, professor of pediatrics and emergency medicine, Harvard Medical School, and chief, Division of Emergency Medicine, Boston Children’s Hospital, said in a press statement from MeMed. “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.”
The technology has received the CE mark in Europe and AMAR clearance from the Israeli Ministry of Health.