Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has strengthened its US rollout strategy for its flagship FebriDx® test — a rapid, 10-minute point-of-care assay that helps clinicians distinguish between bacterial and non-bacterial respiratory infections — signing a strategic collaboration with US med-tech data platform AcuityMD to sharpen visibility around real-world reimbursement patterns.
The partnership is designed to help Lumos navigate one of the most critical — and most challenging — levers in US diagnostic adoption: establishing dependable, repeatable reimbursement across private and public payers.
The move comes as Lumos steps up its US rollout with commercial collaborator PRO-spectus, supported by a strong September quarter and expanding pilot activity across primary and urgent care settings.
Read more: Building momentum: Strong quarter underpins Lumos Diagnostics’ US rollout plans
Why reimbursement is the hurdle
While FebriDx® already holds an established Proprietary Laboratory Analyses (PLA) Code (#0442U) with a reference rate of US$41.38, Lumos notes that this amount is only a benchmark. Actual payments vary widely depending on each insurer’s medical policy, contracted rates, and whether providers meet specific billing criteria.
For many diagnostics, this gap between “published” reimbursement and real-world payments is where commercial uptake has often stalled. A test may be fast, accurate and clinically validated — but if physicians are not consistently reimbursed for using it, repeat ordering and broader adoption can lag.
The collaboration with AcuityMD aims to close that visibility gap. AcuityMD’s AI-driven platform partners directly with the Centers for Medicare & Medicaid Services (CMS) and major claims aggregators, harmonising data across more than 330 million US patients to surface payer-specific reimbursement behaviour.
Working alongside PRO-spectus’ field activities, these insights will help confirm whether private insurers are recognising the 0442U PLA rate, where gaps remain, and which regions or provider groups are achieving reliable reimbursement outcomes — all key inputs as Lumos pushes towards scalable utilisation in the US primary and urgent care markets.
Read more: Lumos partners with PRO-spectus to accelerate commercial adoption of FebriDx® in the US
FebriDx and the commercial equation
FebriDx® is a 10-minute, point-of-care test that helps clinicians distinguish between bacterial and non-bacterial respiratory infections, supporting more targeted treatment decisions and helping to curb unnecessary antibiotic use.
The test has gained growing attention in the US amid heightened pressure on antibiotic stewardship programmes and renewed demand for rapid diagnostics. Lumos has been building out its US infrastructure throughout 2025, including manufacturing readiness, commercial partnerships and expanded health-system engagements.
Improving insight into reimbursement performance is the next step, enabling the company to deploy sales resources more efficiently and build the predictable revenue pathways needed for broader market penetration.
Data-driven insights to guide US rollout
AcuityMD CEO and co-founder Mike Monovoukas said the company was “delighted to partner with Lumos” to expand US access to FebriDx®.
“This partnership supports our mission to accelerate the adoption of cutting-edge medical technology,” he said. “With AcuityMD’s insights, Lumos can focus their efforts where FebriDx® will have the greatest impact on patients.”
Lumos Diagnostics CEO Doug Ward added: “Our partnership with AcuityMD represents another important step in strengthening our commercial capabilities in the US. Access to AcuityMD’s data-driven insights will allow us to better understand and respond to reimbursement trends for FebriDx®, supporting our broader goal of driving adoption across healthcare settings.”
Ward said the collaboration — alongside the PRO-spectus partnership — positions Lumos to execute a more focused and effective commercial rollout strategy in the months ahead.