Lumos soars on US wins for FebriDx point-of-care respiratory test

Lumos Diagnostics jumps 18% on US reimbursement wins for FebriDx, its rapid test that distinguishes bacterial vs non-bacterial respiratory infections.

The LDX share price soared after positive news regarding FebriDx reached investors. Pic via Getty Images.

• Lumos secures reimbursement coverage for FebriDx with two Medicare Administration Contractors

• Reimbursement in Palmetto and Novitas regions is at US$41.38/test effective from start of April

• Negotiations continue with remaining five Medicare Administration Contractors

 

Special Report: Lumos Diagnostics is up 18% today after significant milestones in its US reimbursement pathway for FebriDx test, a rapid point-of-care (POC) diagnostic designed to differentiate between bacterial and non-bacterial acute respiratory infections.

Lumos Diagnostics (ASX:LDX) has announced it has secured reimbursement coverage for its proprietary US-manufactured FebriDx POC test with two Medicare Administrative Contractors (MACs) in the US.

Effective from April 2025, Lumos said FebriDx had been added to the Medicare fee schedule in the Palmetto and Novitas regions at US$41.38/test.

The company highlighted the significance of Medicare in the US healthcare reimbursement landscape, noting it accounts for ~20% to 24% of the total payor mix.

There are seven MACs responsible for processing Medicare reimbursements across the United States.

Lumos said it was continuing negotiations with the remaining five, with advanced discussions underway with three.

The company said these included the Noridian, WPS, and CGS jurisdictions, with next steps underway to formalise inclusion to their Medicare fee schedule.

Reimbursement follows set reimbursement rate

Coverage by the MACs follows inclusion for FebriDX from the Centers for Medicare & Medicaid Services (CMS) in the 2025 Clinical Lab Fee Schedule (CLFS).

Under the CLFS, a proprietary laboratory analyses (PLA) code (0442U) was set for FebriDX to be reimbursed at a rate of US$41.38/test from January 1.

Lumos said the CMS set PLA code was a pivotal milestone in securing reimbursement for FebriDx from both government and private insurers.

The company said it affirmed the test’s clinical value and economic viability, marking a critical first step toward widespread US adoption.

The company said payment (coverage) of the PLA code to healthcare providers by the payors (Medicare and private insurance) was not automatic and must be secured.

Source: Lumos Diagnostics

Medicare adoption crucial for private insurers

Importantly, Lumos said Medicare adoption often set a precedent for private insurers, paving the way for broader reimbursement acceptance.

The company said reimbursement coverage, particularly from private payors, traditionally followed real-world use.

Lumos field teams are actively supporting claim appeals to help them secure insurance coverage by assisting with medical necessity documentation and capturing clinician feedback.

The company said this on-the-ground effort was expected to drive continued adoption and broaden coverage throughout 2025 and into 2026.

Reimbursement pathways cover CLIA-waived settings

Lumos said its reimbursement pathway already encompassed both Moderately Complex and Clinical Laboratory Improvement Amendments CLIA-Waived settings.

The company said that should it be successful with having FebriDx CLIA waived, this will in time enable seamless transition across the two testing environments, without repeating the reimbursement process.

CLIA waivers are granted by the US Food and Drug Administration (FDA) and allow certain diagnostic tests to be performed in non-laboratory settings, such as doctors’ offices, urgent care centres, and pharmacies, by individuals who are not trained laboratory personnel.

The tests are considered simple and pose a low risk of incorrect results. Lumos has partnered on a CLIA waiver study with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response.

At conclusion of the study, which is forecast to run through the US summer season of CY25, Lumos hopes to achieve a successful reclassification of FebriDx from moderate complexity to a CLIA-waived device.

Addressing significant global health challenge

FebriDx can distinguish between bacterial and non-bacterial infections at point-of-care and is considered a critical capability, given that most acute respiratory infections stem from viruses and do not require antibiotics.

Despite this, antibiotics are prescribed in up to 50% of such cases, contributing to the growing issue of antibiotic resistance.

The World Health Organization said the global rise in antibiotic resistance posed a significant threat, diminishing the efficacy of common antibiotics against widespread bacterial infections.

Lumos said the US faced significant challenges in this area, with antibiotic resistance leading to ~2.8 million illnesses and 35,000 deaths annually.

As Medicare adoption increases, Lumos expects the positive cascading effect to influence the decision of private insurers to consider adopting coverage.

The company said this would further validate FebriDx’s role in improving clinical outcomes, reducing unnecessary antibiotic prescriptions, and enhancing patient care.

‘Critical step in building the reimbursement framework’

Lumos managing director Doug Ward said it was extremely pleasing to achieve some early wins with two of the seven US MACs.

“This is an important and critical step in building the reimbursement framework to support clinical adoption for FebriDx,” he said.

“Manufactured proudly in the US FebriDx is not only addressing a critical clinical need in primary care, urgent care and emergency medicine, but it is also supporting American jobs and innovation in point-of-care diagnostics.”

This article was developed in collaboration with Lumos Diagnostics, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as Lumos soars on US wins for FebriDx point-of-care respiratory test