Diagnostic manufacturer, MeMed, announced the completion of its multi-year development of MeMed BV Flex, a test designed to expand the reach of MeMed BV into decentralized, CLIA-waived settings. 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.1
“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,” Adam Singer, MD, vice chairman for Research, Department of Emergency Medicine at Stony Brook University, said in a statement. “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.”1
This new test was verified in a prospective analytical study, demonstrating performance comparable to advanced laboratory methods. In a preprint of a study published on 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.
In a previous interview on Contagion’s podcast, MeMed’s co-founder and CEO Eran Eden, PhD, detailed the overarching goal for creating these diagnostics.
“It [the MeMed BV test] tries to solve the following seemingly simple problem: a patient, a kid or adult comes to urgent care or to an ED [emergency department] with a suspected acute infection. Broadly, we’re trying to discern the etiologies of a bacterial or viral infection. Do we treat or not treat with antibiotics?” Eden said.2