Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has completed a further milestone under its BARDA-funded FebriDx® paediatric clinical study, enrolling 250 patients in the trial.
The achievement marks milestone number 7 under the company’s agreement with the Biomedical Advanced Research and Development Authority (BARDA), which is supporting the study of FebriDx in children aged 2 to 12 years.
The study is assessing use of the rapid point-of-care diagnostic device in CLIA-waived settings, with the aim of supporting a future US Food and Drug Administration submission.
Completion of the milestone triggered a US$670,000 payment to Lumos, which has now been received.
The company has now received US$2.59 million in milestone payments to date under the BARDA Paediatric Study agreement.
If all 12 milestone events are achieved — including clinical trial set-up, patient recruitment, FDA submission and FDA granting of 510(k) clearance and CLIA-waiver categorisation for children — Lumos would receive a total of US$6.198 million across the full agreement.
“The paediatric study continues to progress, and we look forward to the day that we can support clinicians in accurately assessing acute respiratory infections in younger children,” Lumos Diagnostics CEO and managing director Doug Ward said.
What the milestone means for Lumos
The FDA clearance and CLIA waiver, granted on March 27, 2026, substantially broaden FebriDx’s commercial opportunity in the US.
Lumos said the clearance expands FebriDx’s US total addressable market 15-fold to more than US$1 billion per annum.
It also provides access to more than 300,000 locations holding a Certificate of Waiver, including primary care physician offices, urgent care clinics, retail health and pharmacy clinics, and community health centres.
These settings cover around 80 million acute respiratory consultations each year.
What FebriDx does
FebriDx is a 10-minute point-of-care test designed to help healthcare professionals distinguish between bacterial and non-bacterial respiratory infections.
The test is intended to support more informed clinical decision-making and may help reduce unnecessary antibiotic prescribing.
What’s next
With the expanded clearance in place, Lumos is positioned to pursue broader US market access for FebriDx across decentralised healthcare settings where rapid respiratory infection testing can support frontline clinical decisions.