FDA CLIA Waiver Pending: Risks Loom Over Lumos’ Pediatric FebriDx Expansion

Expanding FebriDx’s Reach to Pediatric Care

Lumos Diagnostics Holdings Ltd (ASX, LDX) has announced a significant step forward in broadening the application of its rapid point-of-care diagnostic test, FebriDx. Supported by a $6.2 million non-dilutive funding package from the U.S. Biomedical Advanced Research and Development Authority (BARDA), Lumos will undertake a clinical study to evaluate FebriDx’s use in children aged 2 to 12 years within CLIA-waived settings across the United States.

FebriDx is currently FDA 510(k)-cleared for patients aged 12 to 64 years, primarily in urgent and emergency care environments, to help differentiate bacterial from non-bacterial acute respiratory infections. This new pediatric study aims to extend that clearance to younger patients and enable use in less complex clinical settings, such as primary care offices and pediatric clinics.

Market Implications and Regulatory Pathway

If successful, the CLIA waiver for pediatric use would dramatically expand Lumos’ addressable market in the U.S. from approximately 18,000 clinical sites to 270,000, increasing the potential market size to over $1 billion. This expansion would also cover an estimated 80 million acute respiratory consultations annually, a substantial opportunity for Lumos to embed FebriDx as a frontline diagnostic tool for pediatric respiratory infections.

The study is slated to begin in the third quarter of 2025 and aims to complete patient enrollment within a single respiratory season, with subsequent dual submissions for FDA 510(k) clearance and CLIA waiver. BARDA’s funding is milestone-based, tied to key events such as trial setup, patient recruitment, and regulatory submissions, underscoring the strategic partnership’s focus on timely progress and regulatory success.

Strategic Significance and Future Outlook

Doug Ward, CEO of Lumos Diagnostics, emphasized the importance of BARDA’s ongoing support, highlighting the potential to improve pediatric care by providing clinicians with a rapid, instrument-free test that can reduce unnecessary antibiotic prescriptions. The pediatric study follows a recently completed CLIA waiver study in adults, reflecting a clear pathway to broaden FebriDx’s clinical utility.

While the study and regulatory approvals remain subject to clinical outcomes and FDA review, this initiative positions Lumos at the forefront of rapid respiratory diagnostics in a market segment with significant unmet needs. The partnership with BARDA not only provides critical funding but also validates the public health importance of FebriDx in managing respiratory infections.