FDA Clears MeMed BV Direct From Whole Blood

MeMed has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use of the MeMed BV test on whole blood samples on the point-of-need MeMed Key analyzer.  to help healthcare providers distinguish between bacterial and viral infections in 15 minutes.
 
Through newly developed technology, MeMed BV on whole blood can accurately and quickly measure multiple proteins present in low concentrations from a small volume of whole blood. An earlier version of the test conducted on serum (cleared by the FDA in 2021) is being rolled out successfully in medical centers on the MeMed Key platform as well as on high throughput analyzers through partnerships with diagnostic companies.

“The FDA clearance of MeMed BV on whole blood is a significant milestone in our journey to make bacterial versus viral infection testing a standard of care,” MeMed CEO Eran Eden said. “This enhancement to enable testing on whole blood allows for even easier use, faster results, and maintains the same level of performance, leading to improved patient care now being available across broader settings in the care continuum. 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. 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.”
 
This new version of MeMed BV retains thel performance of its serum counterpart but eliminates the need for clotting and spinning, enabling MeMed to approach decentralized settings in the United States, such as urgent care centers, where minimal handling and maintenance are essential.
 
“This enhancement to the MeMed BV test is an exciting development. The fact that the test can now be carried out directly on whole blood means minimal handling and a reduced burden in the clinical setting alongside a bacterial versus viral decision with shorter patient waiting times. I anticipate that this will enhance both patient and physician satisfaction,” said Dr. Sridevi Devaraj, professor of Pathology and Immunology at Baylor College of Medicine. 
 
MeMed’s mission is to translate the immune system’s complex signals into simple insights that transform the way diseases are diagnosed and treated, profoundly benefiting patients and society. By leveraging expertise in host-response profiling and machine-learning algorithms, MeMed is creating a portfolio of tests that address tough clinical dilemmas.