The AI-powered host-response test is designed to distinguish bacterial from viral infections using a few drops of capillary blood in 15 minutes.

MeMed announced that the Food and Drug Administration (FDA) has granted Breakthrough Device Designation to MeMed BV Flex, an investigational test designed to accurately distinguish between bacterial and viral infections based on the body’s immune response.

The test measures multiple immune proteins from a few drops of capillary blood and applies machine-learning algorithms to generate a clinically actionable score in 15 minutes. It runs on the MeMed Key platform and is intended, pending regulatory clearance, for use across hospitals as well as CLIA-waived and decentralized care settings.

The FDA reserves Breakthrough Device Designation for technologies addressing life-threatening or irreversibly debilitating conditions that demonstrate the potential to significantly improve the standard of care. The designation provides prioritized and more interactive FDA engagement, accelerating development and regulatory review. BDD also provides eligibility to Medicare’s New Technology Add-on Payment alternative pathway and Transitional Coverage for Emerging Technologies, programs that may support broader Medicare coverage and strengthen market access, according to the company.

“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,” says Kristi K. Trimm, MD, TrustCare Health, in a release. “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.”

Capillary Sampling Designed to Expand Access

By combining capillary sampling with laboratory-level analytical performance, MeMed BV Flex™ is designed to expand accessibility, particularly for children and the elderly, according to the company.

“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,” says Eran Eden, PhD, CEO and co-founder of MeMed, in a release. “It also validates our core technology with applications extending well beyond infectious diseases. 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.”

Prior FDA Designations for MeMed

MeMed BV is the first FDA-cleared host-immune response test for accurately distinguishing between bacterial and viral infections in 15 minutes. The company’s MeMed Severity has also previously received FDA Breakthrough Device Designation as a host-response test designed to predict severe outcomes up to 72 hours and mortality 14 days in advance in patients with acute infections and suspected sepsis, though it has not yet been cleared for sale in any territory.

MeMed BV Flex is an investigational device and has not been approved or cleared for sale by any regulatory authority.

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