Lumos Diagnostics Hits 250 Patient Milestone in Paediatric FebriDx Study

Paediatric Study Advances with 250 Patients Enrolled

Lumos Diagnostics (ASX:LDX) has achieved the seventh milestone in its BARDA-funded FebriDx paediatric clinical study by enrolling 250 patients aged 2 to 12 years. This milestone triggered a US$670,000 payment, bringing total milestone payments under the agreement to US$2.59 million. The study, which began in October 2025, aims to validate FebriDx’s rapid point-of-care test in children, enabling differentiation between bacterial and non-bacterial acute respiratory infections in CLIA-waived settings.

Completion of this study is a critical step toward preparing a formal submission to the US Food and Drug Administration (FDA) for 510(k) clearance and CLIA waiver for paediatric use. If all 12 milestones, including clinical trial setup, patient recruitment, and regulatory approvals, are met, Lumos stands to receive a total of US$6.2 million from BARDA to support this project.

Expanding FebriDx’s US Market Reach

The paediatric trial builds on FebriDx’s recent FDA 510(k) clearance with a CLIA waiver for patients aged 12 to 64 years, granted in March 2026. This regulatory milestone unlocked a US$1 billion-plus addressable market in the US, spanning over 300,000 healthcare locations including urgent care clinics, retail health centres, and primary care offices. The expanded market covers approximately 80 million acute respiratory consultations annually, a fifteenfold increase from previous indications.

FebriDx’s rapid, 10-minute test supports clinicians in making informed decisions about antibiotic prescribing, potentially reducing unnecessary use. The paediatric study aims to extend these benefits to younger patients, a demographic where accurate and timely diagnosis is particularly critical.

Strategic Funding and Commercial Momentum

BARDA’s non-dilutive funding remains a cornerstone of Lumos’ clinical development strategy, with the agency committing US$6.2 million across the entire paediatric study. This funding model de-risks the clinical pathway and aligns with Lumos’ broader commercial ambitions following a recent US$1.3 million FebriDx order from its exclusive US distributor, PHASE Scientific.

CEO Doug Ward emphasised the company’s commitment to supporting clinicians with accurate diagnostic tools for acute respiratory infections in children, reflecting ongoing progress in the trial and regulatory process. Lumos is expected to provide further updates as additional milestones are achieved, including the eventual FDA submission and clearance decision.

These developments come amid Lumos’ broader US commercial rollout, which has been bolstered by the FDA clearance and milestone payments that underpin growth and product adoption in a highly competitive diagnostics market. The company’s recent capital raising and manufacturing contracts complement the clinical progress, positioning Lumos to capitalise on FebriDx’s expanded market potential.

Given the complexity and duration of regulatory approvals, the timing of the final FDA decision remains uncertain. However, the steady achievement of enrolment and trial milestones provides tangible evidence of progress toward expanding FebriDx’s use in paediatric care.

Investors and observers will note how these clinical milestones dovetail with Lumos’ recent FDA CLIA waiver unlocks US market and largest FebriDx order secured, underscoring the commercial traction behind the technology.