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FDA CLIA Waiver Unlocks $1B US Market for Lumos Diagnostics’ FebriDx®
10:22am on Friday 27th of March, 2026 AEDT
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Healthcare
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FDA CLIA Waiver Unlocks $1B US Market for Lumos Diagnostics’ FebriDx®
10:22am on Friday 27th of March, 2026 AEDT
Key Points
US FDA grants CLIA waiver and 510(k) clearance for FebriDx®
Milestone payments of US$5.5 million triggered from Phase Scientific and BARDA
Addressable US market expands to 80 million patients annually
Market opportunity grows 15-fold to over US$1 billion
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