FDA CLIA Waiver Decision Looms: Can Lumos Unlock FebriDx’s Massive US Potential?
Lumos Diagnostics has reached 50% recruitment of bacterial positive patients in its pivotal FebriDx CLIA waiver clinical study, setting the stage for a planned FDA submission in late 2025 and unlocking a substantial US market opportunity.
- 61 of 120 bacterial positive patients enrolled, marking 50% recruitment milestone
- Total patient enrollment at 439, nearing 500-patient milestone triggering $298,457 BARDA payment
- Study expected to complete by Q4 2025 with FDA CLIA waiver application planned for October
- Successful CLIA waiver could open access to a US market exceeding $1 billion
- FebriDx enables rapid differentiation of bacterial vs non-bacterial respiratory infections at point-of-care
Clinical Study Progress and Significance
Lumos Diagnostics (ASX, LDX) has announced a key milestone in its ongoing clinical study aimed at securing a CLIA waiver from the U.S. Food and Drug Administration (FDA) for its FebriDx test. The company has now enrolled 61 bacterial positive patients, achieving 50% of the targeted 120 bacterial positive cases required for the study. Overall, 439 patients have been recruited, with the next milestone of 500 patients expected to trigger a payment of nearly $300,000 from the Biomedical Advanced Research and Development Authority (BARDA), Lumos’ funding partner.
The CLIA waiver is a critical regulatory step that would allow FebriDx to be used in a wider range of healthcare settings, including physician offices and urgent care clinics that do not have high-complexity laboratory certification. This broader access is expected to significantly expand the commercial potential of FebriDx in the U.S.
Market Opportunity and Strategic Implications
FebriDx is a rapid, point-of-care diagnostic tool that distinguishes bacterial from non-bacterial acute respiratory infections using a simple fingerstick blood test. This capability supports clinicians in making faster, more informed treatment decisions, particularly around antibiotic use, which is crucial in combating antimicrobial resistance. Lumos estimates that a successful CLIA waiver could unlock a U.S. market opportunity exceeding $1 billion, potentially expanding FebriDx’s addressable market by up to 15 times compared to its current scope.
Managing Director Doug Ward highlighted the importance of reaching the halfway mark in bacterial positive patient recruitment, emphasizing the company’s focus on delivering a successful outcome. The study’s bacterial prevalence rate has improved from 14% to around 35% since implementing an enrichment strategy, accelerating progress toward completion.
Next Steps and Outlook
The clinical study is on track to conclude by the fourth quarter of 2025, with Lumos planning to submit its CLIA waiver application to the FDA shortly thereafter. The company continues to collaborate closely with clinical partners to maintain recruitment momentum and data quality. Investors and industry watchers will be keenly observing the study’s final results and the FDA’s response, which will be pivotal in determining FebriDx’s future commercial trajectory in the U.S.
Overall, Lumos Diagnostics’ progress in this study represents a significant step toward expanding access to innovative point-of-care diagnostics that could reshape respiratory infection management and antibiotic stewardship.
Bottom Line?
As Lumos approaches study completion, the impending FDA decision could redefine FebriDx’s role in US healthcare.
Questions in the middle?
- Will the FDA grant the CLIA waiver as anticipated in late 2025?
- How will Lumos scale production and distribution if the waiver unlocks the $1 billion market?
- What impact will FebriDx have on antibiotic prescription rates and healthcare costs post-approval?
