Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has received a further milestone payment of just over US$500,000 from the US Biomedical Advanced Research and Development Authority (BARDA) after securing CLIA waiver status for its FebriDx® rapid respiratory infection test, adding fresh momentum to the company’s US commercial rollout efforts.
The payment of US$507,377 brings total funding received under the CLIA waiver study program to nearly US$3 million, providing Lumos with additional non-dilutive funding as it advances broader clinical programs, including paediatric studies.
The milestone follows a string of recent developments for the company as it shifts from regulatory execution into commercial expansion, with FebriDx now gaining traction across urgent care and primary care networks in the US.
“BARDA’s assistance provides not only meaningful non-dilutive funding that extends our capacity to run critical studies, including our paediatric program, but also brings technical expertise as we advance our diagnostic solutions toward broader clinical use,” Lumos chief executive officer Doug Ward said.
CLIA waiver opens broader US market
The latest payment relates directly to Lumos achieving CLIA waiver clearance from the US Food and Drug Administration for FebriDx, a key regulatory milestone announced earlier this year.
The waiver significantly expands where the test can be used, allowing deployment across more than 300,000 healthcare sites in the US, including physician offices, urgent care clinics, pharmacy clinics and community health centres operating under Certificate of Waiver licences.
FebriDx is designed to help clinicians distinguish between bacterial and non-bacterial respiratory infections within 10 minutes at the point of care, potentially reducing unnecessary antibiotic prescribing and improving treatment decisions.
Lumos said the expanded classification increases the commercial opportunity for FebriDx to a market estimated at more than US$1 billion annually — roughly 15 times larger than the opportunity available under its previous moderate-complexity designation.
The company estimates the test could now potentially reach around 80 million patients each year in US primary care and urgent care settings presenting with acute respiratory infections.
Rollout momentum building
The BARDA payment adds to a growing list of operational and commercial milestones for Lumos in recent months.
In April, the company confirmed the expansion of its WellStreet Urgent Care rollout to 43 sites across the US, while also receiving a separate US$5 million milestone payment tied to the FebriDx commercialisation program.
Lumos has also recently raised additional capital through a share purchase plan as it pushes further into what management has described as its commercial growth phase following the CLIA waiver breakthrough.
The company has increasingly focused investor attention on scaling adoption of FebriDx across decentralised healthcare settings, particularly as respiratory illness management and antibiotic stewardship remain major priorities in the US healthcare system.
With regulatory clearance now secured and additional BARDA funding in hand, Lumos appears increasingly focused on converting those milestones into broader commercial uptake.