Lumos Diagnostics (ASX: LDX) Expands FebriDx US Rollout as Cash Burn Rises

Lumos Diagnostics has expanded the US rollout of its FebriDx respiratory infection test to 265 live healthcare sites across 29 states, while another 485 sites are conducting clinical and economic evaluations.

The live network had grown by 50 sites, or 23%, since 15 September 2026, while the evaluation pipeline increased by 80 sites. Thirteen of the 100 largest US urgent care groups now have live sites or are evaluating the test, providing an important measure of Lumos’ progress since FebriDx received a CLIA waiver in March.

That waiver opened FebriDx to more than 300,000 US locations operating under a Certificate of Waiver. The test uses a fingerstick blood sample to help clinicians distinguish bacterial from non-bacterial acute respiratory infections in 10 minutes.

Three additional top-100 urgent care groups, collectively representing more than 120 locations, have committed to evaluations across 50 sites. Lumos estimates those evaluation sites treat about 250,000 acute respiratory infection patients annually.

Separately, a primary care network in the US Northeast has committed to immediate deployment across more than 12 locations. The network has over 300 primary care providers and is estimated to treat more than 50,000 acute respiratory infection patients each year.

Product growth offsets weaker services revenue

Unaudited revenue for the September quarter was US$2.04 million, down 39% from US$3.36 million a year earlier. The comparison included a one-off US$1 million exclusivity fee from distribution partner PHASE Scientific in the prior period.

Product revenue rose 224% to US$564,000, including a 351% increase in FebriDx revenue. Services revenue fell 32% to US$1.48 million, partly because lower amortisation of the Hologic intellectual property licence reduced reported revenue by US$500,000 compared with the prior corresponding period.

Lumos’ exclusive US distribution agreement with PHASE was previously valued at US$317 million over six years. Lumos records FebriDx revenue when products are shipped to PHASE. Current shipments are being offset against a US$5 million prepayment received in April, meaning that revenue does not produce a matching cash receipt during this period.

Cash runway and paediatric study remain key watchpoints

Lumos reported a US$4.7 million operating cash outflow for the quarter, including a US$1 million inventory build before the US respiratory season, alongside spending on sales, marketing and the paediatric study. The company ended September with US$11.8 million in cash, no debt and an estimated 2.5 quarters of funding at the reported cash-burn rate.

The paediatric study has enrolled about 400 patients, but both total enrolment and bacterial-positive cases are below the study plan. Lumos will add three hospital emergency departments during the second quarter and plans to discuss possible study-parameter changes with the FDA and BARDA by the end of calendar 2026. No changes have yet been agreed.

Existing US commercialisation for patients aged 12 to 64 is unaffected. Lumos estimates a successful paediatric indication could expand FebriDx’s US addressable market by 15% to 20%.