Highlights

  • Product revenue rose 224% to US$0.56 million as US sites went live.
  • FebriDx live at 265 sites across 29 states, with 485 sites in evaluation.
  • Cash of US$11.8 million at 30 September 2026, with no debt.
  • New Carlsbad manufacturing facility scheduled to open by end of CY2026.

Lumos Diagnostics Holdings Limited (ASX:LDX) has released its Q1 FY27 results and commercial update for the quarter ended 30 September 2026. The update focuses on the US rollout of its FebriDx test following CLIA waiver, along with financial results and manufacturing progress. All figures are unaudited and in US dollars.

FebriDx Commercial Rollout

As at 11 October 2026, FebriDx was live at 265 sites across 29 states, an increase of 50 sites and three states since 15 September. A further 485 sites were in evaluation, up 20% over the same period.

Thirteen of the top 100 US urgent care groups are now engaged, with five live and eight evaluating. CEO Doug Ward said the commercial momentum since securing CLIA waiver for FebriDx continues to exceed expectations.

Quarterly Financial Results

Product revenue increased 224% to US$0.56 million, from US$0.17 million, as US sites went live. Total revenue fell 39% to US$2.04 million, mainly due to lower Hologic IP amortisation, while services revenue declined 32% to US$1.48 million.

Net operating cash outflow was US$4.7 million. Lumos ended the quarter with US$11.8 million in cash and no debt, after a US$1.0 million inventory build ahead of the flu season.

Paediatric Study and Manufacturing

The BARDA-funded paediatric study for children aged 2 to 12 has enrolled about 400 patients, and Lumos has received US$2.6 million of up to US$6.2 million in funding. Enrolment and bacterial-positive cases are below plan, and the company will discuss the study with the FDA by the end of CY2026.

A new ISO 13485-certified manufacturing facility in Carlsbad, California is scheduled to open by the end of CY2026, with capacity for up to 10 million tests a year once validated. The company's AGM is scheduled for 13 November 2026.

Key Takeaways

  • FebriDx adoption in the US is growing, with live sites and evaluations both increasing.
  • Product revenue rose sharply, while total revenue declined due to lower IP amortisation.
  • Lumos remains debt-free with US$11.8 million in cash.
  • Paediatric study enrolment is below plan, with FDA discussions due by end of CY2026.