Lumos Diagnostics reported a strong surge in FebriDx® sales alongside positive FDA feedback, securing full Medicare reimbursement and advancing key clinical studies.
- FebriDx® sales increased 4.3 times year-on-year in Q2 FY26
- FDA CLIA waiver application progressing with positive feedback, decision expected by March 2026
- 100% Medicare reimbursement coverage secured across all US jurisdictions
- BARDA-supported paediatric study underway with 90 patients enrolled
- Cash balance at US$3.0 million with an unused US$5.0 million loan facility
Strong Sales Momentum for FebriDx®
Lumos Diagnostics has delivered a notable performance in the second quarter of FY26, with FebriDx® sales soaring to 4.3 times the revenue recorded in the same period last year. This rapid point-of-care diagnostic test, designed to distinguish bacterial from non-bacterial respiratory infections within 10 minutes, continues to gain traction across the United States, accounting for the majority of product revenue despite an overall slight decline in total revenue year-on-year.
Regulatory Progress and FDA Engagement
The company is advancing steadily towards securing a CLIA waiver from the US Food and Drug Administration (FDA), a critical regulatory milestone that would allow FebriDx® to be used in a broader range of healthcare settings without the need for specialised laboratory personnel. Lumos has responded promptly to FDA feedback, implementing minor updates to user instructions and conducting supplementary usability assessments. The positive tone of FDA interactions suggests the waiver decision is on track for the end of the first quarter of calendar year 2026.
Reimbursement and Market Expansion
Lumos has achieved full Medicare reimbursement recognition across all seven Medicare Administrative Contractor jurisdictions in the US, unlocking access to over 100% of the Medicare payment landscape. This milestone significantly strengthens the commercial foundation for FebriDx®, with the company now focusing on securing formal written coverage policies and engaging private payers to broaden reimbursement. Additionally, Lumos expanded its European footprint by securing a distribution agreement for the Baltic region, enhancing product availability in Lithuania, Estonia, and Latvia.
Clinical Studies and Development Pipeline
The BARDA-supported paediatric study targeting children aged 2 to 12 years is progressing well, with 90 patients enrolled by the end of December 2025. This study aims to expand the market for FebriDx® by approximately 15-20% upon successful completion and regulatory approval. Meanwhile, Lumos continues to advance development projects with partners such as Hologic, focusing on next-generation women’s health diagnostics, and Aptatek Biosciences, working on an in-home monitoring tool for phenylketonuria (PKU).
Financial Position and Outlook
Despite a net operating cash outflow of US$1.0 million for the quarter, Lumos maintains a solid cash position of US$3.0 million and holds an unused loan facility of A$5.0 million (approximately US$3.3 million). The company’s disciplined approach to managing expenses and advancing key milestones positions it well for upcoming regulatory decisions and commercial scaling. CEO Doug Ward emphasised the company’s focus on regulatory execution, reimbursement expansion, and international growth as pillars for long-term value creation.
Bottom Line?
With the FDA CLIA waiver decision imminent and reimbursement foundations solidified, Lumos is poised for a pivotal phase of commercial expansion.
Questions in the middle?
- Will the FDA grant the CLIA waiver for FebriDx® by the end of Q1 2026 as anticipated?
- How quickly can Lumos convert Medicare reimbursement recognition into formal coverage policies and private payer agreements?
- What impact will the BARDA paediatric study results have on FebriDx®’s market penetration and revenue growth?