—MeMed BV Flex™ simultaneously measures multiple host proteins, paired with machine learning, to deliver highly accurate results in 15 minutes from just a few drops of blood—

—Designed for use in decentralized, CLIA-waived settings, the test has been analytically verified in a study to deliver results comparable to standard laboratory methods—

MeMed, a global leader in host-response diagnostics, today 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 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.

“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.”

“Running MeMed BV Flex from a simple finger stick will make advanced host-response testing more widely accessible, not just for pediatric patients, but also in decentralized settings,” said Adam Singer, M.D., Vice Chairman for Research, Department of Emergency Medicine at Stony Brook University. “It means fewer venipunctures for children, faster answers for seniors, and smarter antibiotic use across the board. This breakthrough will empower care providers to distinguish bacterial from viral infections in real time.”

*MeMed BV Flex has not been approved for sale by any regulatory authority.

About MeMed

At MeMed, our 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.

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

MeMed Severity™ has received FDA Breakthrough Device Designation as a host-response test designed to aid early risk assessment in ED patients with suspected infection or sepsis. It predicts severe outcomes within 72 hours and mortality within 14 days. MeMed Severity is not yet cleared for sale in any territory.

Follow and connect with MeMed via LinkedIn, X, and Facebook.

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@memeddx completes development of first-ever fingerstick host-response test for rapid differentiation of bacterial and viral infections