Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has started its FebriDx® CLIA-waived pediatric study in the United States, with the enrolment of the first patient. The study is being conducted in partnership with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR).
The trial will evaluate the use of the FebriDx® rapid point-of-care diagnostic test in children aged 2 to 12 years, aiming to determine its effectiveness in distinguishing between bacterial and non-bacterial acute respiratory infections in a CLIA-waived setting.
The multicentre study will take place across approximately 20 clinical sites in the US, enrolling between 500 and 800 participants to ensure sufficient bacterial case data. The trial is expected to run for about 12 months, after which Lumos plans to submit results to the US Food and Drug Administration (FDA) for 510(k) clearance and CLIA-waiver categorisation for the younger age group.
BARDA is providing non-dilutive funding of up to US$6.2 million to support the study, tied to the achievement of 12 milestone events including trial setup, recruitment and regulatory submissions. To date, Lumos has completed and invoiced US$1 million in milestones, with US$400,000 received in cash.
A successful outcome will enable FebriDx® to expand its diagnostic use in the US from the current 12–64 age range to include children aged 2–12, broadening its clinical reach in pediatric care.
Doug Ward, CEO of Lumos Diagnostics, said: “The commencement of this study marks an important milestone for FebriDx® and our commitment to aiding healthcare professionals in improving infection diagnosis in children. A successful outcome would represent a significant step forward in helping healthcare professionals quickly and confidently differentiate bacterial and non-bacterial acute respiratory infections in children aged 2 to 12 years, supporting better treatment decisions and antibiotic stewardship.”
US$1 billion addressable market
FebriDx® is currently FDA 510(k)-cleared for patients aged 12–64 years who present to urgent care or emergency departments with suspected acute respiratory infection (ARI), when symptoms have lasted fewer than seven days and testing occurs within three days of fever onset.
On August 15, 2025, Lumos — supported by BARDA — submitted a request to the FDA to expand FebriDx® from moderately complex use into CLIA-waived settings. If approved, the expansion would lift Lumos’ US total addressable market roughly 15-fold to more than US$1 billion, broaden site access from about 18,000 to 270,000 locations, and cover around 80 million annual acute respiratory consultations. The submission also seeks an age extension that would give clinicians — including the ~60,000 who treat children aged 2–12 years — another point-of-care aid to help differentiate bacterial ARIs from non-bacterial causes.
The project has been funded in whole or in part with federal funds from the US Department of Health and Human Services (HHS), the Administration for Strategic Preparedness and Response (ASPR) and the Biomedical Advanced Research and Development Authority (BARDA).
Lumos partners with WellStreet to advance FebriDx® testing in Atlanta
The news comes shortly after Lumos inked a deal with WellStreet Urgent Care to progress testing and reimbursement pathways for its FebriDx® rapid host-response test via WellStreet’s JV with Piedmont Urgent Care in Atlanta, Georgia.
