Lumos Diagnostics has lodged its application with the US FDA for CLIA waiver classification of its FebriDx® rapid test.
FebriDx® can distinguish bacterial from non-bacterial respiratory infections in around ten minutes — a tool that could cut down on unnecessary antibiotic use, and recent clinical trial data exceeded targets.
Lumos Diagnostics' CEO Doug Ward said: "We are very pleased with the successful results of our CLIA waiver study for FebriDx® and the timely submission of our application to the FDA. The anticipated granting of CLIA waiver will expand our US addressable market by around 15 times to over US$1 billion.”
FDA feedback is expected by the end of the first quarter of 2026.
#ASX #LumosDiagnostics #FebriDx #FDA #CLIAWaiver #Healthcare #Diagnostics #AntibioticStewardship #MedicalTechnology #ClinicalTrials