Lumos Diagnostics (ASX:LDX) has announced that the US Food and Drug Administration (FDA) has granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for its flagship point-of-care test, FebriDx®, following its 510(k) clearance. Lumos Diagnostics is a leading point of care diagnostics company focused on improving the diagnosis and management of acute infectious and inflammatory conditions. The CLIA waiver significantly expands the applicability of FebriDx® in the US healthcare market.
The granting of the CLIA waiver triggers milestone payments totalling US$5.5 million. This includes US$5.0 million from Phase Scientific and US$0.5 million from the Biomedical Advanced Research and Development Authority (BARDA). The waiver also unlocks a substantial US$1.0+ billion market opportunity, representing a 15-fold increase in the addressable market for FebriDx®, now encompassing approximately 80 million patients annually in the US.
Previously, FebriDx® usage was limited to moderate complexity clinical settings, primarily hospitals and laboratories. The CLIA waiver allows for deployment in over 300,000 locations across the US, including primary care physician offices, urgent care clinics, retail health and pharmacy clinics, and community health centres holding a Certificate of Waiver.
According to Lumos Diagnostics CEO, Doug Ward, the FDA’s decision marks a transformative moment, significantly broadening patient access to FebriDx® and enabling healthcare professionals in outpatient clinics to deliver rapid and accurate results for more effective patient outcomes. The company’s pediatric study, with continued support from BARDA, aims to further extend the benefits of FebriDx® to younger patient populations, supporting more informed antibiotic prescribing across a wider age group.
