Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has submitted its application to the US Food and Drug Administration (FDA) for Clinical Laboratory Improvement Amendments (CLIA) waiver classification for its FebriDx® test. FebriDx® is a rapid, point-of-care test that differentiates bacterial from non-bacterial respiratory infections in about 10 minutes, potentially reducing unnecessary antibiotic use.
The clinical trial data surpassed performance targets, triggering milestone payments of about US$1.3 million from the Biomedical Advanced Research and Development Authority (BARDA) and US$1.5 million from distribution partner Phase Scientific.
FDA feedback is expected by the end of the first quarter of calendar year 2026. If approved, FebriDx’s US market opportunity could expand fifteen-fold to more than US$1 billion.
“We are very pleased with the successful results of our CLIA waiver study for FebriDx® and the timely submission of our application to the FDA. This milestone represents the culmination of significant effort from the Lumos team and our partners. I’d like to extend our sincere thanks to BARDA for their substantial support in helping us achieve this outcome,” Lumos Diagnostics CEO Doug Ward said.
Ward added that FDA findings are expected in early 2026 and said: “The anticipated granting of CLIA waiver will expand our US addressable market by around 15 times to over US$1 billion.”
Clinical trial results
The clinical study demonstrated strong operator concordance, with 99.1% accuracy between trained and untrained operators testing bacterial-positive patients, and 98.4% for non-bacterial patients.
The study was designed to highlight the device’s ease of use and low risk of erroneous results by untrained users — the key criteria for CLIA waiver categorisation. Lumos said the findings underline FebriDx’s simplicity, strengthening its case for expanded access to the US point-of-care market.
Milestone payments
Lumos, which specialises in rapid diagnostic technologies, offering assay development, manufacturing, and proprietary tests targeting infectious and inflammatory disease, expects to receive US$1.25 million in milestone payments from BARDA following the submission, with a further US$507,000 contingent on FDA approval.
The submission also triggers a US$1.5 million product purchase prepayment from Phase Scientific. If granted, CLIA waiver status will activate an additional US$5 million pre-paid purchase commitment under the distribution agreement.
Lumos partners with PRO-spectus to boost US adoption of FebriDx®
It’s been a big week for Lumos, which last week entered a partnering agreement with US-based market access consultancy PRO-spectus to accelerate the marketing, adoption, and reimbursement of its point-of-care diagnostic, FebriDx®.
Read more: Lumos partners with PRO-spectus to accelerate commercial adoption of FebriDx® in the US
While Medicare reimbursement is already in place, the company is now targeting private insurers, which account for around 60% of the US health insurance market and cover more than 170 million people. This requires a dual approach to secure agreements with both the largest insurers, who dominate nearly half the market, and a wide range of smaller payors. The agreement is set to run until December 2026.
Under the partnership, PRO-spectus will provide strategic and operational support, including consulting services to highlight the test’s clinical and economic value, a reimbursement helpline for coding and payment queries, and field-based access managers to work with key healthcare accounts. These functions will integrate with Lumos’ sales team to ensure providers are equipped with the resources needed to adopt FebriDx® and secure consistent reimbursement. The collaboration is designed to broaden patient access, improve clinical decision-making, and contribute to healthcare system efficiency by supporting more accurate diagnoses and reducing unnecessary antibiotic use.