• Lumos completes 250-patient enrolment milestone for FebriDx paediatric study
• Triggers US$670,000 milestone payment, bringing total to US$2,590,000
• Successful outcome to support expanded use of FebriDx in the US

Lumos Diagnostics has announced the successful completion of milestone #7: enrollment of 250 patients in the Biomedical Advanced Research and Development Authority (BARDA) funded FebriDx® paediatric clinical study. The successful completion of this milestone triggers a US$670,000 milestone payment under Lumos' agreement with BARDA, which has now been received. Lumos has now received a total of US$2,590,000 in milestone payments to-date under the BARDA Paediatric Study agreement. If all 12 milestone events, including clinical trial set-up, patient recruitment, US Food and Drug Administration (FDA) submission, and FDA granting of 510(k) clearance and CLIA-waiver categorization for children, are achieved, Lumos will receive a total of US$6,198,459 from BARDA across the entire agreement. This study assesses 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 (from the commencement date on 22 October 2025) to meet statistical endpoint[s], following which a formal submission will be prepared for the FDA. A successful outcome will support broadening the use of FebriDx® in the US as a diagnostic tool for differentiating bacterial from non-bacterial acute respiratory infections to include patients aged 2-64 years.

Lumos will continue to provide updates as further milestones are achieved for the FebriDx paediatric study.