Lumos Reports US$3.5M Q3 Revenue, Medicare Reimbursement at $41.38 per FebriDx Test
Lumos Diagnostics reported a 21% quarter-on-quarter revenue increase in Q3 FY25, driven by strong product sales and expanded development agreements. The company also secured Medicare coverage in key US regions and advanced its pivotal FebriDx CLIA waiver study with FDA submission expected by year-end.
- Q3 FY25 revenue rose 21% quarter-on-quarter to US$3.5 million
- FebriDx sales growth and expanded Hologic development agreement
- Medicare coverage secured in four US regions at $41.38 per test
- FebriDx CLIA waiver study progressing with FDA application targeted for late 2025
- Operating cash outflow improved to US$1.3 million; cash balance US$4.0 million
Quarterly Financial Performance
Lumos Diagnostics (ASX: LDX) delivered a solid operational update for the third quarter of FY25, reporting unaudited revenue of US$3.5 million. This represents a 21% increase over the previous quarter, although revenue remains 13% below the same period last year, reflecting a strategic shift in revenue recognition and product mix. The company’s product segment grew 17% quarter-on-quarter, driven by increased sales of FebriDx and Binx tests, while services revenue rose 22%, underpinned by development agreements including an expanded scope with Hologic.
Despite the year-on-year revenue dip, Lumos demonstrated improved cash management, reducing its operating cash outflow to US$1.3 million from US$3.7 million in Q2 FY25. The company ended the quarter with a cash balance of US$4.0 million, supported by BARDA reimbursements and disciplined expense control.
Strategic Partnerships and Development Progress
A highlight of the quarter was the expansion of the Hologic fFN development agreement, which is expected to generate an additional US$0.6 to US$0.8 million in fee revenue. This collaboration focuses on adapting Hologic’s pre-term birth diagnostic test to Lumos’ proprietary reader platform, with the project timeline extended to December 2025 to accommodate additional hardware features.
Lumos also advanced its Burnet Diagnostics Initiative engagement, completing production of liver function test kits and custom readers for a US clinical trial that commenced in February 2025. This contract is expected to generate between US$0.7 million and US$1.0 million in fees over the coming months.
FebriDx® Market Access and Regulatory Milestones
FebriDx®, Lumos’ rapid point-of-care test for acute bacterial respiratory infections, continues to gain traction. The company secured Medicare Fee Schedule coverage in four of seven US Medicare Administrative Contractor regions, covering over 55% of Medicare payment volume, at a reimbursement rate of US$41.38 per test effective April 2025. Discussions with the remaining three regions are progressing, potentially paving the way for comprehensive national coverage.
The pivotal FebriDx CLIA waiver study is underway, with 351 patients tested to date, including 37 bacterial-positive cases. Although bacterial prevalence has been lower than anticipated, Lumos implemented an enrichment strategy in late March to accelerate enrollment. Study completion and FDA application submission are targeted for the second half of calendar 2025.
In addition, Lumos extended its supply agreement with Atomo Diagnostics for the FebriDx Pascal cassette, securing exclusivity through June 2031 and reinforcing supply chain stability for the test.
Product Portfolio and Competitive Landscape
While FebriDx and Binx products showed strong sales growth, 48% and 73% respectively year-on-year, ViraDx™ faced competitive pressures from low-cost international suppliers, resulting in an 11% sales decline. Nevertheless, ViraDx maintained market presence with new customer acquisitions aligned with the US flu season’s timing shift.
Lumos is also progressing a pipeline of women’s sexual health point-of-care diagnostics, with five potential products in early development stages. The company aims to transition at least one product into formal development within the next 6 to 8 months, signaling a strategic focus on expanding its diagnostic portfolio.
Quality and Compliance Achievements
The company successfully passed its ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) surveillance audits with zero findings, underscoring the robustness of its quality management system. These certifications are critical for maintaining regulatory compliance across multiple jurisdictions including the US, Canada, and Australia.
Outlook and Priorities
Looking ahead, Lumos is focused on accelerating FebriDx adoption in US urgent care centers, expanding payor coverage, and delivering key development milestones with Hologic. The company also plans to advance its women’s health diagnostics pipeline and complete the FebriDx CLIA waiver study to enable broader market access.
CEO Doug Ward emphasized the strategic progress made, highlighting Medicare coverage gains and the expanded Hologic collaboration as key endorsements of Lumos’ technology platform. He expressed confidence in sustained revenue growth driven by commercial traction and regulatory achievements.
Bottom Line?
With Medicare coverage expanding and pivotal studies progressing, Lumos is poised for a transformative year ahead.
Questions in the middle?
- Will the FebriDx CLIA waiver study meet its revised bacterial positive enrollment targets on schedule?
- How quickly will the remaining Medicare Administrative Contractors approve FebriDx coverage?
- What impact will competitive pricing pressures have on ViraDx’s market share and profitability?
