Lumos Diagnostics (ASX:LDX) Commences FebriDx CLIA Waiver Study
Key Highlights
Lumos Diagnostics (ASX: LDX) has initiated the FebriDx CLIA Waiver study in the United States, successfully testing its first patient. The study aims to assess the FebriDx device’s ability to improve antibiotic stewardship by helping clinicians distinguish between bacterial and non-bacterial infections.
The study plans to enroll between 500 and 800 patients across six sites, targeting 120 positive bacterial cases. Completion is anticipated by the upcoming US spring season of 2025. The Biomedical Advanced Research and Development Authority (BARDA) is backing the endeavor with US$2,984,571 in previously announced non-dilutive funding.
Financial Milestones
With the study’s official commencement, Lumos has invoiced BARDA for two milestone payments worth US$925,217. Payment for these milestones is expected by the end of January 2025. The first milestone covers study preparation and launch, while the second pertains to the first patient enrolled.
Executive Comments
Doug Ward, Managing Director of Lumos Diagnostics, stated, “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.”
Future Outlook
The culmination of the study may lead to the reclassification of FebriDx from moderate complexity to a CLIA-waived device. This change could drastically extend its market reach in the US, increasing potential customer sites from 18,000 to approximately 270,000. This expansion presents a market opportunity valued at around US$1.7 billion annually.
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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