• Securing pivotal US$317m exclusive distribution agreement with PHASE Scientific for FebriDx®
• Completion of FebriDx® CLIA waiver clinical study and submission to U.S. FDA
• Achieved 100% Medicare reimbursement recognition across all seven U.S. MAC jurisdictions
• Commencement of BARDA funded CLIA waived paediatric clinical study for FebriDx®

Lumos Diagnostics has reported its financial results for the six months ended 31 December 2025 (1H FY26), highlighting a series of pivotal achievements across its Products and Services businesses. Key highlights include securing a six-year exclusive US$317 million distribution agreement with PHASE Scientific for FebriDx® in the U.S. market, completing the clinical study and submitting the application to the FDA for CLIA waiver classification of FebriDx®, commencing the BARDA funded CLIA-waived paediatric study for FebriDx®, and achieving 100% Medicare reimbursement recognition across all seven U.S. MAC jurisdictions. The company also reported positive operating cash flow of $0.8 million, an improvement of $7.1 million over the prior corresponding period, and received $2.75 million in non-dilutive grant funding. While revenue was slightly lower at $6.12 million compared to $6.31 million in the prior period, gross profit margin improved to 68%. The company remains focused on securing FDA CLIA waiver for FebriDx®, executing the PHASE Scientific distribution agreement, driving reimbursement adoption, and completing the paediatric study, while also delivering on development milestones for its commercial partners and advancing its own women's health pipeline.

Lumos expects to receive a $5.0 million non-refundable, pre-paid purchase commitment from PHASE Scientific upon the granting of FDA CLIA waiver for FebriDx®.

Lumos remains laser-focused on securing FDA CLIA waiver for FebriDx® within the coming month, executing its PHASE Scientific distribution agreement, continuing to drive reimbursement adoption, and completing the paediatric study to further expand the U.S. market opportunity. The company is also committed to delivering key development milestones for its commercial partners and advancing its own women's health pipeline, positioning Lumos for sustainable growth.