• Lumos has completed Milestone 6 tied to total number of enrolled patients in its BARDA-funded paediatric clinical study
• Completion of the milestone triggers a milestone payment of US$720,000
• A total of US$1,920,000 in milestone payments have been received for this study to-date

Lumos Diagnostics Holdings Ltd (ASX: LDX) has completed an enrollment milestone (Milestone 6) in its ongoing Biomedical Advanced Research and Development Authority (BARDA)-funded paediatric clinical study for its FebriDx product. Completion of this enrollment milestone triggers a US$720,000 milestone payment under the company's contract with BARDA. Together with the previously achieved milestones, Lumos has generated a total of US$1,920,000 in milestone payments to-date for the paediatric study. The total value of all milestone payments under this contract is US$6,198,459 from BARDA to Lumos if all 12 milestone events, including clinical trial set-up, patient recruitment, U.S. Food and Drug Administration (FDA) submission, and FDA granting of 510(k) clearance and CLIA-waiver categorization for children, are achieved. 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. Currently, FebriDx is FDA 510(k)-cleared for use in the U.S. in patients aged 12-64 years presenting to urgent care or emergency care settings for evaluation of acute respiratory infection who have had symptoms for less than 7 days and within 3 days of fever onset.

A successful outcome of the paediatric study will support the broadening of FebriDx's use in the U.S. to include patients aged 2-64 years.