Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has secured a significant expansion of the US commercial rollout for its flagship FebriDx test, with WellStreet Urgent Care agreeing to deploy the rapid point-of-care respiratory test across an additional 43 locations following a successful initial pilot.
The move marks a step-up from a single-site program and comes shortly after the test received CLIA waiver clearance from the US Food and Drug Administration, a key milestone that enables broader use in point-of-care settings.
The expanded rollout will take place over the next two months, covering sites across Georgia and Michigan, and could pave the way for adoption across WellStreet’s full network of 163 urgent care centres.
That network represents a sizeable opportunity, with around 1.1 million patients presenting annually with acute respiratory symptoms — a key target market for FebriDx.
From pilot to scaled deployment
The initial program, launched in October 2025 at a Piedmont Healthcare joint venture site in Atlanta, provided operational and clinical validation, handling roughly 50 respiratory cases per day.
With that groundwork in place, Lumos is now moving into a broader commercial phase.
Under the expanded agreement, FebriDx will be offered to all patients presenting with acute respiratory infection symptoms under a standing order protocol. This brings diagnostic insight forward in the care pathway, supporting faster triage and more timely treatment decisions.
WellStreet’s leadership pointed to the role of point-of-care diagnostics in improving both workflow and clinical outcomes, particularly in guiding treatment decisions and reducing unnecessary antibiotic use.
Chief operating and medical officer Dr Michael Duchynski said expanding FebriDx across the network “supports our commitment to evidence-based care and helps ensure every patient gets the right treatment, faster”.
Senior medical officer Dr Brian Bobb added that integrating the test into clinical workflows gives providers “actionable data before they even enter the exam room,” noting that this level of precision “directly supports better patient outcomes and antibiotic stewardship”.
Volume, visibility and contracting leverage
For Lumos, the move is not just about test volumes — it also opens the door to wider adoption across large provider networks.
“The expansion into the additional WellStreet locations represents an important next step for FebriDx, by increasing test volume across a broader geographic footprint, improving payor visibility, and strengthening our position in future contracting discussions with potential new providers,” Lumos CEO Doug Ward said.
The development follows Lumos’ earlier announcement today of a US$5 million milestone payment tied to the CLIA waiver for FebriDx, which has paved the way for expanded rollout across US care settings.
If the current phase proves successful, Lumos expects WellStreet to extend FebriDx across its remaining locations over the next six to 12 months, effectively transitioning from a pilot program to network-wide deployment.
That potential pathway would see FebriDx embedded across one of the larger urgent care networks in the US, providing a clearer line of sight to scaled adoption as Lumos continues to build out its commercial footprint.