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Lumos Diagnostics Holdings Limited (ASX:LDX)

ALERT: Price-sensitive ASX Announcement for LDX
Current share price for LDX : $0.115 -0.15 (-56.60%)+
Announcement
Release
27 Mar 2026 10:08AM
Price at Release
$0.265
Full Release
download
Summary
The US FDA has granted a CLIA waiver for Lumos Diagnostics' FebriDx, expanding its usability to over 300,000 US locations and unlocking a market opportunity exceeding US$1 billion. This clearance triggers milestone payments totalling US$5.5 million and positions Lumos to reach 80 million patients annually in the US, broadening the applicability of FebriDx to various healthcare settings. It marks a significant commercial milestone for Lumos Diagnostics, enhancing the management of acute respiratory infections in outpatient clinics.
Key Points
  • US FDA grants CLIA waiver for FebriDx.
  • Triggers milestone payments of US$5.5 million.
  • Expands FebriDx's market opportunity to over US$1 billion.
  • Allows FebriDx to be used in 300,000 locations across the US.
  • Positioned to reach 80 million patients per year in the US.
  • Broadens FebriDx's applicability to primary care and urgent care settings.
  • Significant commercial achievement for Lumos Diagnostics.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.