Summary:
MeMed has unveiled MeMed BV Flex, a rapid fingerstick-based test that distinguishes bacterial from viral infections in 15 minutes, expanding host-response diagnostics into decentralized, CLIA-waived settings.
Takeaways:
- Decentralized Accessibility: MeMed BV Flex enables rapid, lab-quality infection diagnostics in near-patient and pediatric settings using just a fingerstick, improving access and patient comfort.
- Proven Accuracy: Analytical studies show strong concordance between capillary and venous blood, supporting clinical reliability for real-time decision-making.
- Platform Expansion: The new test integrates machine learning and supports a broader pipeline of assays, paving the way for future applications in sepsis, immune monitoring, and reaching one million patients.
MeMed, a global provider of host-response diagnostics, has 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 fingerstick.
“Running MeMed BV Flex from a simple fingerstick will make advanced host-response testing more widely accessible, not just for pediatric patients, but also in decentralized settings,” says Adam Singer, MD, 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.”
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,” says Eran Eden, PhD, 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.”
Featured Image: The MeMed BV test enables accurate differentiation between bacterial and viral infections in just 15 minutes using only a few drops of capillary blood from a fingerstick. Image: MeMed
*MeMed BV Flex has not been approved for sale by any regulatory authority.
