Lumos Diagnostics Achieves Key Milestone in FebriDx Clinical Study

An announcement from Lumos Diagnostics Holdings Ltd. ( (AU:LDX) ) is now available.

Lumos Diagnostics has achieved a significant milestone in its FebriDx CLIA waiver clinical study by enrolling its 500th patient, triggering a milestone payment from its partner BARDA. The study aims to secure a CLIA waiver from the U.S. FDA, which would allow broader use of FebriDx in various healthcare settings, potentially unlocking a U.S. market exceeding $1 billion. With the study expected to conclude by Q4 2025, Lumos plans to submit its CLIA waiver application in October 2025, which could enhance point-of-care decision-making and antibiotic stewardship in the U.S. healthcare system.

More about Lumos Diagnostics Holdings Ltd.

Lumos Diagnostics specializes in rapid and complete point-of-care diagnostic test technology to help healthcare professionals more accurately diagnose and manage medical conditions. Lumos offers customized assay development and manufacturing services for point-of-care tests and proprietary digital reader platforms. Lumos also directly develops, manufactures, and commercializes novel Lumos-branded point-of-care tests that target infectious and inflammatory diseases.

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