• 510(k) clearance with CLIA waiver for FebriDx issued by the US FDA
• Triggers key milestone payments of US$5.5 million
• Expands addressable market to approximately 80 million patients per annum

The US FDA has granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for Lumos Diagnostics' (ASX:LDX) flagship point-of-care test, FebriDx, following its 510(k) clearance [K260787]. This clearance and granting of the CLIA waiver triggers milestone payments of US$5.5 million under agreements with PHASE Scientific and the Biomedical Advanced Research and Development Authority (BARDA) and expands the applicability of FebriDx to over 80 million US patients per annum and a total market opportunity of US$1.0+ billion, representing a 15-fold increase on the market opportunity prior to CLIA waiver. The CLIA waiver expands the applicability of FebriDx to over 300,000 locations across the US, covering a broad range of healthcare settings, spanning primary care physician offices, urgent care clinics, retail health & pharmacy clinics and community health centres that hold a Certificate of Waiver. This milestone marks a significant commercial achievement for Lumos, positioning FebriDx to reach tens of millions more patients without the need for complex laboratory infrastructure or specialised training. This expanded opportunity aligns with Lumos' US commercial strategy, which includes support from the Company's partnerships with PRO-spectus, AcuityMD and PHASE Scientific.

The CLIA waiver triggers milestone payments of US$5.0 million from Phase Scientific and US$0.5 million from BARDA, further strengthening Lumos' balance sheet and providing additional funding to support the broader US commercial rollout of FebriDx.

Looking ahead, with the continued support of BARDA, Lumos is excited with the opportunity to further broaden patient access to FebriDx, through its pediatric study. If successful, this important initiative would enable the use of FebriDx in younger patient populations, extending the benefits to children 2 to 12 years of age and supporting more informed antibiotic prescribing across a wider age group.