Lumos Diagnostics Holdings (ASX: LDX) has completed Milestone 6 in its Biomedical Advanced Research and Development Authority (BARDA)-funded paediatric clinical study, triggering a US$720,000 milestone payment. The Lumos Diagnostics Paediatric Study Milestone brings total payments received to date to US$1,920,000, representing progress towards the contract’s full value of US$6,198,459 across 12 milestones.
The milestone completion demonstrates operational momentum in the company’s clinical expansion programme, which aims to broaden FebriDx® eligibility to children aged 2 to 12 years within CLIA-waived settings. This government-backed funding structure provides non-dilutive capital, reducing shareholder dilution risk whilst advancing the regulatory pathway for market expansion.
Key milestone payment figures:
- Current payment: US$720,000
- Cumulative payments to date: US$1,920,000
- Total contract value: US$6,198,459 (across all 12 milestones)
What is BARDA and why does government-backed funding matter?
The Biomedical Advanced Research and Development Authority (BARDA) operates within the U.S. Department of Health and Human Services, supporting the development of medical countermeasures and technologies with public health significance. BARDA contracts provide structured milestone-based funding for projects deemed strategically important to national health security.
For investors, BARDA funding delivers three material advantages:
- Validation: Government backing signals technical merit and strategic relevance of the underlying technology
- Non-dilutive capital: Milestone payments fund clinical development without issuing new shares or debt
- Funding visibility: Pre-defined milestone structure provides clarity on potential payment timing and amounts
This funding model reduces execution risk by removing the need for capital raises during critical development phases, whilst the achievement of successive milestones demonstrates tangible clinical progress.
Paediatric expansion unlocks significant market opportunity
FebriDx® currently holds FDA 510(k) clearance for patients aged 12 to 64 years presenting to urgent care or emergency care settings for evaluation of acute respiratory infection (symptoms less than 7 days, fever within 3 days of onset). The paediatric study aims to extend this clearance to children aged 2 to 12 years within CLIA-waived settings.
The study is expected to run for approximately 12 months to meet statistical endpoints, following which a formal FDA submission will be prepared. A successful outcome would enable an estimated 60,000 clinicians treating children aged 2 to 12 years to access FebriDx® as a diagnostic aid for differentiating bacterial acute respiratory infections from non-bacterial causes.
| Parameter | Current Clearance | Target Expansion |
|---|---|---|
| Age Range | 12-64 years | 2-64 years |
| Setting | Moderately complex | CLIA-waived |
| U.S. Clinical Sites | 18,000 | 270,000 |
The paediatric age extension represents a distinct market expansion opportunity beyond the company’s existing clearance. If approved, the combined age range of 2 to 64 years would substantially broaden the addressable patient population for FebriDx® deployment.
CLIA waiver application already under FDA review
Separately, Lumos submitted a CLIA waiver application on 15 August 2025, seeking to expand FebriDx® use from moderately complex settings into CLIA-waived settings for the existing adult patient population. If granted, this CLIA waiver could expand the company’s U.S. total addressable market 15-fold to over US$1.0 billion, providing access to 270,000 clinical sites (compared to 18,000 currently) and covering approximately 80 million annual acute respiratory consultations.
Market expansion metrics:
- 15-fold increase in addressable market
- US$1.0 billion+ total addressable market opportunity
- 270,000 accessible clinical sites (vs 18,000 under current clearance)
The company is pursuing two parallel regulatory pathways: CLIA waiver approval for adult patients and paediatric clearance expansion. These represent distinct catalysts that could materially expand commercialisation opportunities across different patient demographics and care settings.
CEO signals strong enrolment momentum
Management has highlighted operational progress in achieving the enrollment milestone, noting the team’s rapid mobilisation and delivery of strong enrolment momentum.
Doug Ward, CEO
“Completing this enrollment milestone in our paediatric study is an important operational milestone on the path to lodging a formal submission. The team has mobilised quickly and has delivered strong enrolment momentum. We look forward to the day that we can better support clinicians in the assessment of acute respiratory infections in children through the use of FebriDx®.”
The company has committed to providing updates as further milestones are achieved throughout the study period.
Upcoming milestones and catalysts
With 6 of 12 milestones now completed, the remaining milestone pathway includes continued patient recruitment, study completion, FDA submission, and FDA granting of 510(k) clearance and CLIA-waiver categorisation for children. The total remaining milestone payment potential stands at US$4,278,459.
Key upcoming milestones and catalysts:
- Continued patient enrollment in paediatric study
- Study completion (expected within approximately 12 months)
- Preparation and submission of formal FDA application
- FDA review and potential 510(k) clearance
- CLIA-waiver categorisation approval for children
- Parallel CLIA waiver decision for adult patient expansion
The structured milestone framework provides visibility on near-term catalysts whilst the dual regulatory pathway approach offers multiple opportunities for market expansion across both age demographics and care settings. Each successful milestone completion triggers additional funding and advances the company towards commercial deployment in expanded patient populations.
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