Lumos Diagnostics caps FY26 with FebriDx revenue up 875% and US rollout gaining momentum

Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) finished the fourth quarter of FY26 with strong full-year growth from its flagship FebriDx® rapid diagnostic test, expanding US commercial adoption and closing the period with US$15.4 million in cash.

Unaudited FY26 revenue increased 6% on the previous corresponding period to US$13.2 million, supported by an 875% surge in FebriDx revenue to US$3.9 million as orders increased under Lumos’ exclusive US distribution agreement with PHASE Scientific.

The company recorded a US$2.7 million operating cash inflow during the June quarter, compared with a US$1.7 million outflow a year earlier, following higher customer receipts and milestone payments associated with the US regulatory and clinical development of FebriDx. 

Chief executive officer Doug Ward said commercial adoption had tracked ahead of expectations since the CLIA waiver was secured.

“We are encouraged by the progress achieved since securing CLIA waiver for FebriDx®, with commercial adoption tracking ahead of our expectations,” Ward said.

“These early results reinforce the value proposition of FebriDx® for providers, payers and patients, and validate the significant commercial opportunity ahead of us.”

FebriDx drives product revenue higher

Lumos’ Products division generated FY26 revenue of US$4.3 million, up 135% from US$1.8 million in FY25.

The result was driven primarily by FebriDx, a 10-minute fingerstick blood test designed to help clinicians differentiate between bacterial and non-bacterial acute respiratory infections.

The US Food and Drug Administration granted FebriDx a Clinical Laboratory Improvement Amendments, or CLIA, waiver in March 2026, materially expanding the settings in which the test can be used.

Lumos estimates the waiver increased the test’s addressable US market by about 15 times, opening access to more than 300,000 healthcare locations and over 80 million patients presenting annually with acute respiratory infections.

The expanded market includes urgent care centres, primary care offices, community health centres and retail health and pharmacy clinics.

The regulatory milestone triggered a US$5 million payment from PHASE Scientific and a further US$500,000 payment from the US Biomedical Advanced Research and Development Authority, or BARDA.

US adoption expands across 24 states

Commercialisation is progressing through Lumos’ exclusive US distribution agreement with PHASE, valued at US$317 million over six years.

More than 170 healthcare locations across 24 states were actively ordering and using FebriDx at the date of the quarterly report.

This includes 44 WellStreet Urgent Care locations following an expansion from an initial pilot site in Atlanta. WellStreet plans to extend the rollout across all 165 of its sites over the next three to nine months, with Lumos aiming to activate as many locations as possible before the forthcoming US respiratory illness season.

Early reimbursement outcomes also exceeded expectations, with more than 90% of submitted claims successfully reimbursed.

The Medicare benchmark reimbursement rate is US$41.38 per test, while private payer reimbursement has generally been above that level.

Following the end of the quarter, a leading regional US urgent care operator agreed to deploy FebriDx across more than 30 sites, representing around 200,000 annual acute respiratory infection presentations.

Three additional urgent care groups, including top-10, top-25 and top-30 operators, are also progressing through clinical and economic validation across networks totalling more than 230 sites.

Paediatric program reaches milestone

Lumos continued its BARDA-supported study aimed at expanding FebriDx eligibility to children aged two to 12 in CLIA-waived settings.

The company completed the study’s seventh milestone after enrolling 250 patients, triggering a US$670,000 payment that has since been received.

Lumos has now received cumulative milestone payments of US$2.6 million under the paediatric study agreement.

BARDA has committed up to US$6.2 million across 12 milestones covering clinical trial preparation, patient recruitment and regulatory submissions.

The study began in October 2025 and is being conducted across multiple US clinical sites. Lumos expects to provide a further update on the study and regulatory pathway toward the end of calendar 2026.

Services projects continue to advance

The Development Services and Contract Manufacturing division recorded FY26 revenue of US$8.9 million, down 16%, primarily because the extended Hologic project timeline reduced recognised intellectual property licence revenue.

Excluding that impact, project revenue increased 24% to US$7.5 million, reflecting greater contract research and development activity.

Lumos worked on 12 customer projects during the June quarter, including programs for Hologic, Micro-Pak, TeleMedVet and Aptatek Biosciences.

Its collaboration with Hologic is focused on developing the next generation of Hologic’s fetal fibronectin diagnostic product for assessing the risk of pre-term birth.

The development agreement has expanded through six additional scopes of work and now provides total potential milestone payments of US$7 million to US$7.7 million.

Phase 2 assay feasibility work is expected to be completed by the end of August 2026, while additional assay, hardware and software activities have extended the overall estimated project completion date to around June 2028.

Cash position strengthened

Lumos received US$7 million from customers during the June quarter, including the US$5 million PHASE milestone payment.

The company also received US$1.7 million from government grants and tax incentives, including BARDA payments and the Australian research and development tax incentive.

After investing and financing activities, Lumos reported a net quarterly cash inflow of US$14.2 million and finished June with US$15.4 million in cash.

The balance included US$13.3 million in net proceeds from an institutional placement and share purchase plan, together with US$1.5 million from the exercise of unlisted options.

Lumos fully repaid and closed its A$5 million secured loan facility with Tenmile and Ryder Capital after the reporting period and said it now had no debt.

Next steps

Lumos will focus on increasing FebriDx adoption and utilisation across existing and prospective US healthcare networks, supporting PHASE’s commercial rollout and expanding private payer reimbursement coverage.

The company is also expanding manufacturing capacity at its Carlsbad facility, with building works expected to be completed in November 2026.