Lumos Diagnostics Holdings Ltd (ASX: LDX) has announced a key partnership milestone with the Biomedical Advanced Research and Development Authority (BARDA) to launch a pediatric clinical study for its FebriDx® test. The study will evaluate FebriDx® use in children aged 2–12 years across CLIA-waived settings, with BARDA committing US$6.2 million in non-dilutive funding. FebriDx® is already FDA 510(k)-cleared for patients 12–64 years in urgent or emergency care, but expanding to CLIA-waived environments would significantly broaden its market reach from 18,000 to 270,000 sites, potentially unlocking a US$1 billion opportunity.
The pediatric study is scheduled to begin in Q3 2025, targeting completion within the 2025/26 U.S. respiratory season, with subsequent dual 510(k) and CLIA waiver submissions. This project builds on Lumos’ recent CLIA-waiver study and underscores BARDA’s continued support, enabling wider clinician access, including 60,000 pediatric practitioners, to a valuable diagnostic tool for differentiating bacterial from non-bacterial respiratory infections.
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