Lumos Complete 1st Enrollment Milestone for Paediatric Study
23 February 2026
Lumos has announced the completion of the first enrollment milestone in the ongoing BARDA-funded paediatric clinical study. This achievement marks Milestone 6 under Lumos’ contract with BARDA, triggering a milestone payment of US$720,000.
With this payment, Lumos has now received a total of US$1,920,000 in milestone payments for the study to date. The full contract provides up to US$6,198,459 in non-dilutive funding upon completion of all 12 milestones, including patient recruitment, FDA submission, and receipt of 510(k) clearance and CLIA-waiver categorisation for paediatric use.
The study will assess the use of the FebriDx® device in 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 submission will be prepared for the FDA.
Doug Ward, CEO of Lumos Diagnostics said:
"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."
Click to read the ASX announcement
With this payment, Lumos has now received a total of US$1,920,000 in milestone payments for the study to date. The full contract provides up to US$6,198,459 in non-dilutive funding upon completion of all 12 milestones, including patient recruitment, FDA submission, and receipt of 510(k) clearance and CLIA-waiver categorisation for paediatric use.
The study will assess the use of the FebriDx® device in 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 submission will be prepared for the FDA.
Doug Ward, CEO of Lumos Diagnostics said:
"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."
Click to read the ASX announcement
