Lumos Diagnostics Holdings Ltd - Milestone Order Following FDA Approval

Lumos Diagnostics Holdings Ltd (ASX: LDX) has secured its largest-ever order for FebriDx®, valued at US$1.3 million, from PHASE Scientific, its exclusive US distributor. This order comes shortly after FebriDx® received the US FDA’s 510(k) clearance with a CLIA waiver on March 27, 2026. The clearance opens up a market opportunity worth over US$1.0 billion, expanding the addressable market for FebriDx® by 15 times. 

Doug Ward, CEO of Lumos Diagnostics, highlighted that this significant order validates the commercial potential of FebriDx® in the US. The company is now focused on supporting PHASE in scaling the product’s rollout, which will see broader adoption across urgent and primary care settings. Lumos specializes in point-of-care diagnostic technologies and continues to drive innovations in rapid diagnostic testing.

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