FebriDx
Differentiation of bacterial vs. non-bacterial infection (Acute Respiratory Infections)
CommercialMarket Expansion (FDA CLIA Waiver Granted Mar 2026)
Key Facts
Indication
Differentiation of bacterial vs. non-bacterial infection (Acute Respiratory Infections)
Phase
Commercial
Status
Market Expansion (FDA CLIA Waiver Granted Mar 2026)
Company
About Lumos Diagnostics
Lumos Diagnostics is a specialized diagnostics company with a mission to simplify clinical decisions through rapid, actionable tests at the point of care. The company has achieved significant commercial milestones, including U.S. FDA 510(k) clearance with CLIA waiver for its flagship FebriDx® test, unlocking a major market opportunity, and has secured its largest-ever order for the product. Its strategy combines proprietary product commercialization with a high-margin CDMO service business, utilizing a flexible technology platform centered on lateral flow assays and the Leelu digital reader.
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