• Lumos to commence FebriDx® pediatric study to evaluate use on 2-12 years of age in CLIA-waived settings
• BARDA to support study with US$6.198 million non-dilutive funding package
• Study launch anticipated to commence in Q3 CY2025 to run through the 2025/26 U.S. respiratory season

Lumos Diagnostics Holdings Ltd (ASX: LDX) has announced that the Biomedical Advanced Research and Development Authority (BARDA) has exercised its option to support Lumos in conducting a clinical study and regulatory submission aimed at expanding the age eligibility for FebriDx® use to include 2-12 years in Clinical Laboratory Improvement Amendments (CLIA)-waived settings. Currently, FebriDx® is FDA 510(k)-cleared for use in patients aged 12-64 years presenting to urgent care or emergency care settings for evaluation of acute respiratory infection. The proposed age eligibility extension would enable clinicians, including the 60,000 clinicians treating children 2-12 years of age, to access an additional diagnostic aid for differentiating bacterial acute respiratory infections from non-bacterial causes. The study is anticipated to enroll the first patient in the fall of 2025 (Q3 CY2025), with the target to complete enrolment within a single 12-month respiratory season, followed by dual 510(k)/CLIA waiver submission. The value of this option is US$6,198,459, which increases the overall total value of the contract to $9,183,030, upon completion of all milestones.

If a CLIA waiver is granted, this expansion would increase Lumos' U.S. total addressable market 15-fold to over US$1 billion, providing access to 270,000 clinical sites (currently 18,000), and covering around 80 million annual acute respiratory consultations.