Lumos Faces Timing Pressure as FebriDx Study Nears Critical FDA Submission
Lumos Diagnostics has enrolled 500 patients in its FebriDx CLIA waiver clinical study, unlocking a significant milestone payment from BARDA and moving closer to FDA approval that could open a US$1 billion market.
- 500 patients enrolled in FebriDx CLIA waiver clinical study
- US$298,457 milestone payment received from BARDA
- 78 of 120 bacterial positive patients enrolled, with improved prevalence after enrichment
- Study expected to complete by Q4 2025, FDA CLIA waiver application targeted for October 2025
- Successful CLIA waiver would enable broader US market access exceeding US$1 billion
Milestone Enrollment and BARDA Support
Lumos Diagnostics (ASX, LDX) has reached a pivotal point in its FebriDx CLIA waiver clinical study by enrolling its 500th patient. This achievement triggered a milestone payment of US$298,457 from the Biomedical Advanced Research and Development Authority (BARDA), underscoring the strong partnership backing this innovative diagnostic tool. To date, BARDA has contributed over US$1.2 million in milestone payments, with nearly US$3 million committed in total contingent on regulatory progress.
Progress Toward FDA CLIA Waiver
The study aims to secure a CLIA waiver from the U.S. Food and Drug Administration (FDA), which would allow FebriDx to be used in a wider range of healthcare settings, including physician offices and urgent care clinics that lack high-complexity lab certification. Achieving this waiver is critical for Lumos to expand the reach of FebriDx, a rapid point-of-care test that differentiates bacterial from non-bacterial respiratory infections using a simple fingerstick blood sample.
Bacterial Prevalence and Enrollment Strategy
While 78 bacterial positive patients have been enrolled so far, representing 65% of the target 120, Lumos has implemented an enrichment strategy since March 2025 that has increased the bacterial prevalence rate in the study from 15.6% to approximately 35%. This adjustment is expected to accelerate the completion of the study, which is currently on track to conclude by the fourth quarter of 2025.
Market Potential and Clinical Impact
A successful CLIA waiver would unlock access to a U.S. market exceeding US$1 billion, enabling broader deployment of FebriDx across healthcare settings. The test supports antibiotic stewardship by helping clinicians make faster, more informed decisions at the point of care, potentially reducing unnecessary antibiotic prescriptions and improving patient outcomes. Lumos Managing Director Doug Ward emphasized the company’s confidence in FebriDx’s role in enhancing point-of-care decision-making within the U.S. healthcare system.
Next Steps and Outlook
With enrollment progressing steadily and bacterial prevalence improving, Lumos is poised to complete patient recruitment in the coming months. The next significant BARDA milestone payment of US$746,143 will be triggered upon enrolling the last patient. Subject to successful data outcomes, Lumos plans to submit its CLIA waiver application to the FDA in October 2025, marking a critical step toward commercialisation and broader market access.
Bottom Line?
Lumos is closing in on a regulatory breakthrough that could transform FebriDx into a mainstream diagnostic tool across U.S. healthcare settings.
Questions in the middle?
- Will the enrichment strategy sustain the higher bacterial prevalence needed to meet study targets on time?
- How will FDA regulators respond to the clinical data when the CLIA waiver application is submitted?
- What are the commercial rollout plans and timelines post-CLIA waiver approval?