FDA Clears Groundbreaking MeMed BV Test for Direct Whole Blood Use: Faster Results and Wider Patient Access in Distinguishing Bacterial and Viral Infections
Thursday, July 20, 2023
MeMed, a leader in advanced host response technologies, is thrilled to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for their MeMed BV® test on whole blood samples using the MeMed Key® analyzer. This clearance enables healthcare providers to differentiate between bacterial and viral infections within 15 minutes at the point-of-need.
The MeMed BV test's latest version utilizes innovative technology to accurately and swiftly measure multiple proteins in a small volume of whole blood, even at low concentrations. The earlier version of the test, which received FDA clearance in 2021 for use on serum, has been successfully implemented in medical centers on the MeMed Key platform and high throughput analyzers through partnerships with top diagnostic companies.
With this new clearance, the need for clotting and spinning has been eliminated, enabling MeMed to expand its reach to decentralized settings, such as urgent care centers, where simplified handling and minimal maintenance are crucial. The FDA's approval of MeMed BV on whole blood is a significant step toward making bacterial versus viral infection testing a standard of care.
This improvement in the MeMed BV test allows for easier usage, faster results, and maintains the same high level of performance seen in its serum counterpart, leading to better patient care across a wider range of healthcare settings. By conducting the test directly on whole blood, it reduces handling requirements and alleviates the burden on clinical settings, resulting in quicker decisions for bacterial versus viral infections and shorter patient waiting times. This progress represents an exciting development in infection testing and holds promising benefits for patient care.