MeMed announced the completion of its multi-year development of MeMed BV Flex, an innovative, next-generation test designed to expand the reach of MeMed BV into decentralized, CLIA-waived settings. The test enables accurate differentiation between bacterial and viral infections in just 15 minutes using only a few drops of capillary blood from a finger prick.
The new test was verified in a prospective analytical study. In the published study (read here), capillary and venous blood measurements showed high concordance across all host proteins as well as the MeMed BV score, indicating strong agreement between sample types. The test runs on an enhanced version of MeMed’s existing platform, designed to support rapid, near-patient use. Following initial dialogue with the FDA, a multi-center pivotal study is underway to confirm clinical accuracy and support regulatory submission.
*MeMed BV Flex has not been approved for sale by any regulatory authority.
