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 accessibility of FebriDx in the US healthcare market.
The granting of the CLIA waiver triggers milestone payments totalling US$5.5 million to Lumos. 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 US$1.0+ billion market opportunity, representing a 15-fold increase for FebriDx, expanding its addressable market to approximately 80 million patients per annum.
With the CLIA waiver, FebriDx can now be used 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. This expansion allows for broader patient access without the need for complex laboratory infrastructure or specialised training, aligning with Lumos’ US commercial strategy and partnerships.
Doug Ward, CEO of Lumos Diagnostics, stated that the FDA’s decision marks a transformative moment for Lumos and for the management of acute respiratory infections in the US healthcare system. He highlighted the invaluable support of BARDA and the potential for further expansion through a pediatric study to include younger patient populations, supporting more informed antibiotic prescribing across a wider age group.
