Lumos Diagnostics (ASX: LDX) has announced a significant milestone in its BARDA-funded paediatric study, triggering a US$720,000 non-dilutive payment and advancing its regulatory pathway for broader FebriDx use.
This marks the sixth milestone payment received under the BARDA contract.
The latest payment brings the total milestone payments received from BARDA to US$1.92 million to date.
The total potential BARDA funding across all 12 milestones stands at US$6.198 million.
The paediatric study is designed to evaluate FebriDx in children aged two to 12 years within CLIA-waived settings.
FebriDx Paediatric Market Expansion
The successful completion of the paediatric study is a crucial step.
The company expects the study to take approximately 12 months to meet its endpoints for subsequent FDA submission.
This submission has the potential to allow the use of FebriDx across a broader paediatric population.
Currently, FebriDx holds FDA 510(k) clearance for individuals aged 12-64 years.
A paediatric CLIA-waiver expansion could significantly broaden the total addressable market (TAM) for FebriDx in the US.
This expansion could reach over US$1.0 billion annually across approximately 270,000 sites.
Regulatory and Funding Context
The funding received from BARDA is non-dilutive, which means it provides financial support without requiring the issuance of new shares.
This bolsters Lumos's financial resources as it progresses its regulatory and commercial goals.
BARDA funding has previously supported Lumos's CLIA waiver study and the broader regulatory pathway for FebriDx.
In a separate but related development, Lumos has also secured 100% Medicare reimbursement for FebriDx across all seven Medicare Administrative Contractors (MACs), at US$41.38 per test.
The company aims for FDA submission for expanded paediatric use following the paediatric study's approximately 12-month duration.
Broader Commercial Strategy
Lumos Diagnostics' FY25 Annual Report outlined significant progress in the commercialisation of FebriDx.
This included a pivotal, exclusive US distribution agreement with PHASE Scientific, with a total potential value of US$317 million over its six-year term.
The company has also expanded its distribution networks, partnering with key players like Thermo Fisher, MedPro Associates, MediGroup, and Henry Schein, including expansion into Belgium.
Additionally, Lumos has an ongoing development agreement with Hologic for an fFN test, which holds potential for future revenue streams.
To support these initiatives, Lumos strengthened its balance sheet with an A$10 million equity raise and a binding A$5 million loan facility, as noted in the FY25 Annual Report.
Outlook and Risks
This BARDA milestone payment provides important non-dilutive funding and advances Lumos Diagnostics' regulatory pathway for the FebriDx test in the paediatric population.
While progress is encouraging, regulatory approval and successful market penetration remain contingent on continued study outcomes and execution of commercial strategies.
Investors should be aware that regulatory approval and CLIA-waiver are not guaranteed, paediatric study outcomes and FDA timelines remain uncertain, and funding depends on continued milestone achievements.
