Lumos Diagnostics Secures US$317M Deal as FebriDx Nears FDA Milestone
Lumos Diagnostics reported a 12% revenue increase for FY25 and inked a landmark US$317 million exclusive distribution deal for its FebriDx test, while advancing its FDA CLIA waiver application.
- FY25 revenue rose 12% to US$12.4 million
- Q4 revenue declined 26% due to end of U.S. flu season
- Exclusive US distribution deal with PHASE Scientific valued at US$317 million
- FebriDx CLIA waiver study nearing completion with FDA application expected soon
- Secured A$5 million loan facility to support working capital
Strong Revenue Growth Amid Seasonal Challenges
Lumos Diagnostics closed FY25 with unaudited revenue of US$12.4 million, marking a 12% increase over the previous year. However, the fourth quarter saw a 26% revenue drop to US$2.6 million, primarily due to the seasonal decline following the U.S. flu season. Product revenue grew 7% year-on-year, driven by strong adoption of the FebriDx rapid diagnostic test, which saw a remarkable 522% increase compared to the prior corresponding period.
Landmark Distribution Agreement Unlocks U.S. Market Potential
Post-quarter, Lumos announced a six-year exclusive U.S. distribution agreement with PHASE Scientific valued at up to US$317 million (A$487 million). This deal represents one of the largest ever signed by an Australian point-of-care diagnostics company and includes upfront payments and milestone-based purchase commitments tied to regulatory progress. The partnership is poised to significantly accelerate FebriDx’s market penetration across the U.S.
Regulatory Milestones and Reimbursement Progress
The company is nearing completion of its FebriDx CLIA waiver study, having enrolled 105 of the targeted 120 positive bacterial patients. The FDA application for the waiver is expected within three months, potentially enabling broader use of FebriDx in less complex clinical settings. Lumos has also secured Medicare payor coverage for FebriDx in six of seven U.S. Medicare Administrative Contractor regions, covering approximately 85% of Medicare payors and setting a precedent for private insurance reimbursement.
Ongoing Development and Financial Position
Beyond FebriDx, Lumos continues to advance its collaboration with Hologic on a next-generation pre-term birth diagnostic, with Phase 2 work completed and additional studies underway. The company is also developing a pipeline of women’s sexual health diagnostics, aiming to transition at least one product into formal development within the next 6 to 8 months. Financially, Lumos ended the quarter with US$2.0 million in cash and reported an operating cash outflow of US$1.7 million. To bolster working capital, Lumos secured a binding term sheet for a discretionary A$5 million loan facility from major shareholders, designed to support operations through the anticipated CLIA waiver approval.
Strategic Outlook
CEO Doug Ward emphasized the critical nature of recent milestones, highlighting the distribution deal and regulatory progress as foundational for FebriDx’s future as a platform diagnostic. The company remains focused on completing the CLIA waiver study, expanding reimbursement coverage, initiating a pediatric BARDA study, and advancing product development in women’s health. These efforts collectively aim to enhance patient care and drive sustainable growth for Lumos.
Bottom Line?
With regulatory and commercial milestones converging, Lumos is positioned for a pivotal year ahead, but timely FDA approval and market adoption remain key hurdles.
Questions in the middle?
- Will the FDA grant the FebriDx CLIA waiver on the anticipated timeline?
- How quickly can PHASE Scientific scale U.S. distribution to meet deal expectations?
- What impact will increased competition have on ViraDx and other product lines?
