The infectious disease diagnostic company MeMed is taking a big step toward a larger market of point-of-care settings, courtesy of a new FDA green light for its test that distinguishes between viral and bacterial cases.
The former Fierce 15 winner’s machine learning-powered platform aims to help avoid the misuse of antibiotics at times where they would offer no benefits, and potentially contribute to drug-resistant bugs.
MeMed’s BV blood test also helps healthcare providers track down conditions in adults and children when the site of the infection is unknown, or hard to reach with swabs or other conventional diagnostic methods, by profiling the body’s immune response instead of uncovering the pathogen itself.
While a previous version of the 15-minute test was cleared by the FDA in 2021 for use on collected serum, the latest 510(k) clearance opens the test up to samples of whole blood, eliminating the preparation steps of clotting blood and spinning test tubes.
That can help put the BV test and its Key analyzer in settings such as urgent care centers, which see about 100 million people for potential infections in the U.S. each year, the company estimates.
“The basis of physician prescription of unnecessary antibiotics is diagnostic uncertainty—is the patient presenting with a bacterial or a viral infection? The two are often clinically indistinguishable,” MeMed CEO Eran Eden said in the company’s announcement. “By providing a rapid, reliable solution for differentiating between bacterial and viral infections, this test can help reduce the risk of unnecessary antibiotic prescriptions, one of the key drivers of antibiotic resistance.”
Earlier this year, MeMed inked a deal with Beckman Coulter to jointly develop and commercialize the BV test for the latter’s Access line of immunoassay analyzers. The companies estimated that the underuse of antibiotics for patients with bacterial infections can reach 20%, while the overuse of unneeded antibiotics poses a major global public health threat.