Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has secured a further US$720,000 in non-dilutive funding after completing a key enrolment milestone in its ongoing US paediatric clinical study for FebriDx®, backed by the United States’ Biomedical Advanced Research and Development Authority (BARDA).
The milestone — the sixth contemplated under the BARDA partnership — relates to the total number of patients enrolled to date in the BARDA-funded study. Its completion lifts total milestone payments received under the contract to US$1,920,000.
Under the agreement, BARDA has committed up to US$6,198,459 across 12 milestones covering clinical trial set-up, patient recruitment, US Food and Drug Administration (FDA) submission, and potential FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA)-waiver categorisation for paediatric use.
Expanding into paediatric use
The current study is evaluating the use of FebriDx® in children aged 2 to 12 years in CLIA-waived settings. The trial is expected to run for about 12 months to meet statistical endpoints, after which Lumos intends to prepare a formal submission to the FDA.
FebriDx® is currently FDA 510(k)-cleared in the US for patients aged 12 to 64 years presenting to urgent care or emergency settings with symptoms of acute respiratory infection for less than seven days and within three days of fever onset.
A successful outcome from the paediatric study would support broadening FebriDx®’s US label to include patients aged 2 to 64 years, significantly extending the device’s potential clinical reach.
“Completing this enrolment milestone in our paediatric study is an important operational milestone on the path to lodging a formal submission,” said Lumos CEO Doug Ward.
“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®.”
CLIA waiver pathway in progress
The paediatric trial runs alongside Lumos’ broader regulatory push to secure CLIA-waiver status for FebriDx® in the US.
In August 2025, the company, supported by BARDA, submitted an application to the FDA seeking to expand FebriDx® use from moderately complex laboratory settings into CLIA-waived settings. A CLIA waiver would allow the test to be used in a wider range of point-of-care environments, including physician offices and community clinics.
Lumos says a CLIA waiver could increase its US total addressable market around 15-fold to more than US$1 billion, expanding access from about 18,000 sites to around 270,000 clinical locations and covering an estimated 80 million annual acute respiratory consultations.
If both the CLIA waiver and paediatric indication are secured, FebriDx® would be positioned for use by around 60,000 clinicians treating children aged 2 to 12 years, providing an additional diagnostic aid to help differentiate bacterial from non-bacterial acute respiratory infections.
Non-dilutive funding support
The BARDA contract provides non-dilutive funding tied to clearly defined development and regulatory milestones, reducing capital strain as Lumos advances its US regulatory strategy.
The project is funded in whole or in part by the US Department of Health and Human Services through BARDA under contract number 75A50124C00051.
FebriDx® delivers results in around 10 minutes at the point of care and is designed to support clinical decision-making and potentially reduce unnecessary antibiotic prescribing.
Lumos said it will continue to update the market as further milestones under the BARDA contract are achieved.