With nationwide Medicare reimbursement secured, a paediatric clinical study under way and final US Food and Drug Administration (FDA) feedback addressed, Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) says it is entering the final stages of the US commercialisation pathway for its FebriDx® respiratory test.
The December quarter saw US sales of the product rise more than fourfold year-on-year, positioning the company for a potential acceleration in uptake as it works towards an FDA CLIA waiver decision expected by the end of the March quarter.
For the three months ended December 31, 2025, the company recorded unaudited revenue of US$2.7 million, down 6.9% on the previous corresponding period, reflecting the loss of legacy ViraDx sales. That decline was partly offset by accelerating uptake of FebriDx in the US, which delivered a 4.3-fold increase in sales compared with the previous corresponding period.
Product revenue for the quarter was US$500,000, while services revenue was steady at US$2.2 million, underpinned by ongoing development work for partners including Hologic.
FebriDx commercial progress builds
Momentum continued to build around FebriDx, Lumos’ rapid point-of-care test designed to differentiate bacterial from non-bacterial respiratory infections in around 10 minutes.
Key FebriDx developments during the quarter included:
- US December quarter sales accounting for 93% of total FY25 sales
- Positive and constructive engagement with the FDA following submission of the CLIA waiver application
- Completion of minor instruction updates and a supplementary usability assessment requested by the FDA
- Continued expectation of a CLIA waiver decision by the end of Q1 CY2026
- 100% Medicare reimbursement recognition secured across all seven US Medicare Administrative Contractors
With Medicare representing around 20–24% of the US payer mix, Lumos said full recognition significantly strengthens the reimbursement foundation for broader adoption. The company’s focus is now shifting to formal written coverage policies with individual MACs, alongside engagement with private payers.
Lumos also entered a strategic collaboration with AcuityMD to improve visibility into real-world reimbursement performance, providing claims-based insights to support payer engagement and commercial execution alongside US partner PRO-spectus.
Paediatric study and international expansion
The BARDA-supported paediatric study aimed at expanding FebriDx use to children aged two to 12 progressed well during the quarter, with enrolment commencing in October and around 90 patients enrolled by year end. Lumos has already completed several early milestones, triggering US$1.2 million in milestone payments.
Internationally, the company secured a new distribution agreement with Interlux covering Lithuania, Estonia and Latvia, further expanding its European footprint alongside existing arrangements in markets including the UK, Spain and the Netherlands.
Development services remain a steady contributor
Lumos continued work on around 12 active development projects during the quarter, with the Hologic fFN diagnostic program remaining a major revenue driver.
The expanded Hologic development agreement now spans multiple phases and additional scopes of work, with total milestone payments expected to range between US$6.5 million and US$7.0 million. While parts of the Phase 3 timeline have been extended, Lumos said assay feasibility work under Phase 2 is expected to be completed by the end of February 2026.
Cash position and outlook
The company ended the quarter with US$3.0 million in cash, following a net operating cash outflow of US$1.0 million. A US$3.3 million loan facility remains undrawn.
CEO Doug Ward said the quarter reflected disciplined execution across Lumos’ regulatory and commercial priorities.
“During the quarter, we have made excellent progress with advancing the commercialisation of FebriDx, with particularly encouraging feedback from our engagement with the FDA in progressing our CLIA waiver application,” Ward said. “This keeps us on track and focused on the final steps required to achieve a CLIA waiver.”
He also pointed to the company’s progress across reimbursement, paediatric studies and international distribution positions.
“These achievements reflect our disciplined approach to regulatory execution, commercial readiness and long-term value creation as we work to broaden access to FebriDx not only in the US, but across global markets.”