Rapid Host-Response Test Distinguishes Bacterial and Viral Infections in Minutes
Posted on 18 Mar 2026
MeMed has received Breakthrough Device Designation (BDD) for MeMed BV Flex, a host-response test designed to accurately distinguish between bacterial and viral infections. The assay runs on the MeMed Key platform and is intended, pending regulatory clearance, for use across hospitals as well as Clinical Laboratory Improvement Amendments (CLIA)-waived and decentralized care settings. The approach is positioned to expand accessibility, particularly for children and the elderly.
Using a few drops of capillary blood, the test measures multiple immune proteins and applies machine-learning algorithms to generate a clinically actionable score in 15 minutes. By combining capillary sampling with laboratory-level analytical performance, the system is designed to deliver results historically associated with central laboratory infrastructure. The test is presented as simple to operate to support use across varied points of care.
The U.S. Food and Drug Administration (FDA) reserves BDD for technologies that address life-threatening or irreversibly debilitating conditions and show potential to significantly improve the standard of care. The designation provides prioritized and more interactive FDA engagement, accelerating development and regulatory review, and confers eligibility for Medicare’s New Technology Add-on Payment (NTAP) alternative pathway and Transitional Coverage for Emerging Technologies (TCET). These programs may support broader Medicare coverage, strengthening market access and commercial readiness. MeMed BV Flex is an investigational device and has not been approved or cleared for sale by any regulatory authority.
“This is the kind of diagnostic innovation healthcare has been waiting for. A test that distinguishes between bacterial and viral infections using the body’s immune response and AI can help clinicians make more confident decisions, reduce unnecessary antibiotic use, avoid missed bacterial infections and ultimately improve patient outcomes," said Dr. Kristi K. Trimm, TrustCare Health. "The added flexibility of capillary sampling and CLIA waived status, once granted, could extend that value beyond hospital systems into urgent care and other frontline settings, helping elevate the standard of care across the healthcare continuum.”
“We are grateful for the FDA’s Breakthrough Device Designation, which recognizes the strength of our platform technology and helps streamline our path toward clearance, reimbursement, and ultimately advancing the management of patients with fever and sepsis. It also validates our core technology with applications extending well beyond infectious diseases," said Eran Eden, Ph.D., CEO and Co-Founder of MeMed. "Together with our current and future partners, our unique ability to integrate machine learning with multiplex host-protein measurements from just a few minimally invasive drops of blood opens a broad range of possibilities across neurology, cardiology, autoimmunity, and other immune-mediated conditions.”
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