Quarterly Activities/Appendix 4C Cash Flow Report
| Stock | Lumos Diagnostics Holdings Ltd (LDX.ASX) |
|---|---|
| Release Time | 29 Jan 2026, 2:22 p.m. |
| Price Sensitive | Yes |
Lumos Diagnostics Reports Q2 FY26 Results
- FebriDx® sales up 4.3x over previous quarter
- FDA feedback on CLIA waiver application positive, decision expected by Q1 CY2026
- Secured 100% Medicare reimbursement for FebriDx® across the U.S.
Lumos Diagnostics reported its Quarterly Activity Statement and Appendix 4C Quarterly Cash Flow Report for the second quarter of FY26. The company recorded unaudited revenue of US$2.7 million for the quarter, down 6.9% on the previous corresponding period (pcp), with revenue from the Products business at US$0.5 million and revenue from the Services business at US$2.2 million. FebriDx® sales were up 4.3x over the pcp, driven by increasing adoption across the U.S. The company received feedback from the FDA on its CLIA waiver application for FebriDx®, with the FDA providing recommendations for minor changes to the product instructions and a small supplementary usability assessment, which have now been addressed. Lumos is positive that the CLIA Waiver process remains on track, with a decision expected by the end of Q1 CY2026. The company also secured 100% Medicare reimbursement recognition for FebriDx® across the U.S., a significant milestone that strengthens the reimbursement foundation supporting broader U.S. adoption. Additionally, Lumos made progress on the BARDA-supported FebriDx® paediatric study, with around 90 patients enrolled by the end of December, and continued to execute on the Hologic fFN development project. The company also provided an update on its women's sexual health product development initiatives, with three potential products advancing to the technical feasibility stage.
The key focus areas for Lumos include: securing FDA decision on the CLIA waiver application for FebriDx® by end of Q1 CY2026, securing a US$5.0 million product prepayment from Phase Scientific upon CLIA waiver clearance for FebriDx®, continuing to implement the agreement with PHASE Scientific and drive reimbursement coverage, progressing the BARDA FebriDx® paediatric study, delivering on the Hologic fFN development milestones, and progressing to formal product development for the first Lumos branded women's health diagnostics test.