Lumos adds 50 FebriDx sites as US commercial momentum builds

FebriDx rollout reaches 265 US healthcare sites

Lumos Diagnostics Holdings Ltd (ASX:LDX) has taken FebriDx to 265 live US healthcare sites across 29 states, a gain of 50 sites since its 15 September update. Another 485 sites are conducting clinical and economic evaluations, giving the company a sizeable conversion task as it enters the US respiratory season.

The latest figures extend the acceleration captured in Lumos’ September FebriDx site update, when 215 sites were live and 405 were under evaluation. Five of the top 100 US urgent care groups now have live sites, while eight are evaluating FebriDx. Together, the live sites are estimated to represent 1.1 million to 1.5 million acute respiratory infection visits a year, although those estimates are not the same as confirmed tests, orders or revenue.

Product revenue grows despite lower reported group revenue

Unaudited first-quarter revenue was US$2.0 million, down 39% from US$3.4 million in the prior corresponding period. That headline comparison is distorted by a US$1.0 million one-off PHASE exclusivity fee received in the earlier quarter and by a lower contribution from services revenue.

The Products division generated US$564,000, up 224% year on year, with FebriDx sales increasing 351%. Services revenue fell 32% to US$1.5 million, partly because less of the Hologic intellectual property licence fee was amortised during the quarter. Lumos said development work continued across 12 projects.

New health-system commitments broaden the pipeline

Three additional top 100 urgent care organisations are progressing clinical and economic validation across 50 sites. Lumos estimates those locations treat about 250,000 acute respiratory infection patients annually. A separate Northeast US primary-care network with more than 12 locations and 300 providers has committed to immediate deployment across its sites, where annual respiratory infection visits are estimated at more than 50,000.

One top 100 urgent care group and academic health system has also moved to standardised adoption across more than 20 outpatient settings after provider training. Lumos’ commercial framework now tracks accounts from qualification through evaluation, network rollout and standardised adoption, but the filing does not disclose guaranteed purchase volumes or utilisation per site.

Cash position supports expansion but leaves limited room for delay

Lumos ended 30 September with US$11.8 million in cash and no debt. Operating cash outflow was US$4.7 million, including US$1.0 million invested in inventory ahead of the US respiratory season, along with sales and marketing expenditure, clinical study costs and facility work. The Appendix 4C calculates estimated funding of 2.5 quarters based on the quarter’s operating cash outflow.

The company is also spending on its Carlsbad manufacturing expansion, with about US$400,000 still estimated to be required as work completes by 31 December 2026. The facility is intended to lift capacity towards 10 million tests a year, but the filing does not provide a revised cash-flow forecast tied to that target.

Paediatric study and Hologic program add execution risks

The BARDA-funded paediatric FebriDx study has enrolled about 400 patients, up from 250 in May, but both total enrolment and bacterial-positive cases are below the study plan. Three hospital emergency departments are due to be added in the second quarter, while Lumos and BARDA plan to discuss the study with the FDA by the end of calendar 2026. No change to the study design or timetable has yet been agreed, and current US commercialisation for patients aged 12 to 64 is unaffected.

Separately, work under the Hologic fFN development agreement has pushed the expected project timeline to around June 2028 after additional assay, hardware and software scopes expanded the program. Lumos said it has submitted a proposal for further reader work and is awaiting Hologic’s response. The commercial rollout is therefore advancing, but the next test for the story is whether live-site growth turns into recurring utilisation quickly enough to offset the company’s cash burn.