• Reimbursement rate set by Centers for Medicare and Medicaid Services Panel in US for Lumos’s FebriDx point-of-care test
• The FebriDx proprietary laboratory analyses (PLA) code (0442U) will be reimbursed at a rate of US$41.38/test
• Lumos to engage with US private and government payers and other key stakeholders to establish reimbursement and coverage policies

Special Report: Lumos Diagnostics (ASX: LDX) has achieved a new milestone in the commercial rollout of its FebriDx point-of-care (POC) test to differentiate a bacterial versus non-bacterial etiology (cause of) respiratory infection – with key reimbursement approval in the US.

A leader in rapid, POC diagnostic technologies, Lumos received approval from the Centers for Medicare and Medicaid Services (CMS) Panel for the FebriDx proprietary laboratory analyses (PLA) code (0442U) to be reimbursed at a rate of US$41.38/test.

PLA codes are an addition to the current procedure terminology (CPT) code set approved by the American Medical Association CPT Editorial Panel.

The FebriDx PLA code will be published on the Clinical Lab Fee Schedule and take effect on January 1, 2025.

Lumos said the key CMS approval would play a vital role in securing reimbursement for FebriDx from both government and private insurers.

It is considered a critical step toward enhancing FebriDx’s accessibility and adoption and is expected to facilitate broader use of the test over time by making it more affordable.

Tackling antibiotic resistance

FebriDx can distinguish between bacterial and non-bacterial infections at POC.

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

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.

Next Steps for growth of adoption of test

In addition to implementing FebriDx into clinical pathways, triage workflows and achieving CLIA waiver labelling, Lumos will now engage with US private and government payers, as well as other key stakeholders, to establish reimbursement and coverage policies.

CEO and managing director Doug Ward said the unique PLA code represented a further advancement in the US commercialisation of FebriDx.

“This reimbursement pathway is another important step towards removing barriers to access and potentially benefitting millions of Americans,” he said.

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

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