Lumos Diagnostics Achieves U.S. Medicare Reimbursement Milestones for FebriDx®

Lumos Diagnostics (ASX: LDX) has taken a major step forward in its U.S. market expansion, securing Medicare reimbursement for its rapid diagnostic test, FebriDx®, with two of seven Medicare Administrative Contractors (MACs).

The test will be reimbursed at US$41.38 per test, effective April 2025.

FebriDx® is a 10-minute, point-of-care test that helps distinguish between bacterial and viral respiratory infections—enabling faster, more targeted treatment while curbing overuse of antibiotics adding to the global issue of antibiotic resistance.

In December 2024, the U.S. Centers for Medicare & Medicaid Services (CMS) added FebriDx® to the 2025 Clinical Laboratory Fee Schedule under PLA Code 0442U. That marked a key milestone, but actual reimbursement depends on approval by individual MACs.

Now, Lumos has achieved that next step with Palmetto and Novitas regions. Discussions with Noridian, WPS, and CGS are reported as well progressed, and engagement continues with all seven MACs.

“It is extremely pleasing to achieve some early wins with two of the 7 U.S. Medicare Administration Contractors. This is an important and critical step in building the reimbursement framework to support clinical adoption for FebriDx®.”— Doug Ward, Managing Director, Lumos Diagnostics

Medicare comprises 20% to 24% of the U.S. reimbursement mix and often sets the tone for private insurer decisions. Lumos expects Medicare coverage to trigger broader adoption across private payors.

To support this, Lumos field teams are helping healthcare providers navigate claim appeals, submit medical necessity documentation, and gather clinician feedback—measures aimed at driving real-world uptake.

Importantly, reimbursement already covers both Moderately Complex and CLIA Waived environments. If FebriDx® secures full CLIA Waiver approval, the test could expand into decentralized care settings without restarting the reimbursement process.

“Manufactured proudly in the United States, 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. Lumos looks forward to the day that FebriDx® has broad U.S. reimbursement coverage across both public and private insurers and the team is working to deliver on that objective.”

With early Medicare wins and strong policy alignment, Lumos is building momentum in the world’s largest diagnostics market.

The market capitalisation of LDX is approximately A$21.4M at 2.7 cents per share.