First-Ever Fingerstick Host-Response Test Rapidly Differentiates Between Bacterial and Viral Infections

MeMed BV is the first FDA-cleared host-immune response test for accurately distinguishing between bacterial and viral infections in 15 minutes.

At the “Breakfast Symposium: Unpacking Real-World Impact: MeMed BV in Clinical Practice”, leaders from three academic medical centers shared real-world implementation experiences, each with unique clinical and operational goals for the same diagnostic test. Johns Hopkins Medical Center emphasized clinical performance and physician acceptance, Maimonides Medical Center prioritized diagnostic stewardship and physician adherence, and Texas Children’s Hospital is targeting antibiotic stewardship in complex pediatric populations.

MeMed has also 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, demonstrating performance comparable to advanced laboratory methods.

In the study published in medRxiv, 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.

“Accurately and simultaneously measuring multiple proteins from just a few drops of blood, in a rapid and easy-to-use format, has been a long-standing challenge,” said Eran Eden, Ph.D., Co-founder and CEO of MeMed. “By pairing this breakthrough with machine learning, we’ve enhanced our platform which, once cleared, can help extend host-response testing across broader decentralized use. It’s a major step toward our next goal of reaching one million patients and enables a plug-and-play engine for our broader pipeline, from MeMed Severity to future sepsis and immune-status assays.”

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Beckman Coulter