NEW YORK – Diagnostics firm MeMed said on Monday that it has received US Food and Drug Administration 510(k) clearance for its MeMed BV test on its MeMed Key platform, which measures a panel of host-response proteins to help distinguish between bacterial and viral infections.
According to Haifa, Israel-based MeMed, the test, which measures the levels of three proteins — TRAIL, IP-10, and CRP — in patient blood, will help cut down on antibiotic overuse by allowing doctors to rule out the presence of bacterial infections.
The company added that its reliance on host-response proteins makes it useful even in cases where the site of infection is unknown or inaccessible, or the pathogen is undetectable using conventional methods.
MeMed began offering an ELISA version of the test in 2015 in the EU, Switzerland, and Israel as part of an early access program, and it received CE-IVD marks for the BV test and Key platform last year.
Last year the company also entered a licensing agreement with diagnostics company DiaSorin, giving the firm the right to commercialize the test for use on its Liaison analyzer platform.
"Host-response technologies are a new frontier in the management of adults with infectious diseases, with great potential to improve patient outcomes," Sergey Motov, professor of emergency medicine at Maimonides Medical Center in New York City, said in a statement. "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."
"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," said Rich Bachur, professor of pediatrics and emergency medicine at Harvard Medical School. "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."
FDA clearance was based on a multicenter blinded clinical validation study enrolling over 1,000 children and adults. MeMed has established an office in Boston to drive commercialization of the test in the US.