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Lumos Diagnostics Expands US Market with FDA CLIA Waiver, Triggers US$6.2M Milestones

10:12am on Monday 20th of April, 2026 AEST Healthcare
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Lumos Diagnostics Expands US Market with FDA CLIA Waiver, Triggers US$6.2M Milestones

10:12am on Monday 20th of April, 2026 AEST
Key Points
  • FDA grants 510(k) clearance with CLIA waiver for FebriDx, expanding US addressable market to 80 million patients annually
  • Milestone payments of US$6.2 million triggered from PHASE Scientific and BARDA
  • Q3 FY26 revenue up 37% to US$4.8 million, driven by 243% growth in product sales
  • A$20 million placement completed; Share Purchase Plan underway
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