Fantastic to see Lumos Diagnostics commence their pivotal FebriDx CLIA Waiver study in the US and receive their first two funding milestones from BARDA. The trial will run through US Spring 2025, after which a formal submission will be prepared for the FDA.
Lumos Diagnostics (ASX: LDX) has successfully launched its pivotal FebriDx® CLIA Waiver study in the United States this week, marking a significant step forward for the Company. This study will evaluate the use of the FebriDx device by untrained users in a CLIA waived setting compared to trained professionals. It will be conducted in multiple CLIA Waived clinical sites across the United States. Between 500 and 800 patients are expected to be enrolled for the study. It is anticipated to run through the US spring season 2025, after which a formal submission will be prepared for the FDA. The study, backed by BARDA's strong commitment of US$3M in funding, has already achieved its first two milestones, triggering payments to the value of US$925,217. In addition to funding, BARDA is providing study support, regulatory expertise, and support for the application to obtain a CLIA waiver from the US FDA. Lumo Managing Director, Doug Ward, commented: "We are very pleased to commence this pivotal clinical study, particularly with BARDA's invaluable support. Achieving CLIA-waived status would enable FebriDx to reach a broader market and empower healthcare providers with a reliable tool for delivering accurate and objective health insights to their patients." Read the ASX release 👉 https://lnkd.in/ggKearnp $LDX #LDX #Lumos #diagnostics #pointofcare #healthcare #rapidtest #AMR
