Lumos Signs US$317M Exclusive US Distribution Deal for FebriDx®

A Pivotal US Market Entry

Lumos Diagnostics, an Australian leader in rapid point-of-care diagnostic technologies, has taken a significant step towards expanding its footprint in the lucrative US healthcare market. The company announced a six-year exclusive distribution and supply agreement with PHASE Scientific International Limited, a biotech firm with strong presence in the US and Asia, valued at up to US$317 million (A$487 million). This deal hinges on the successful FDA CLIA waiver approval for Lumos’ FebriDx® test, a rapid diagnostic tool designed to differentiate bacterial from non-bacterial respiratory infections.

Financial Structure and Milestones

The agreement includes an immediate US$2 million payment to Lumos, comprising a US$1 million non-refundable exclusivity fee and a US$1 million pre-paid purchase order. Additional milestone payments of US$1.5 million and US$5 million are scheduled upon the FDA CLIA waiver application submission and approval respectively. These upfront and milestone payments underscore PHASE Scientific’s commitment and confidence in FebriDx®’s market potential.

Should all minimum order quantities be met over the contract term, Lumos stands to receive the full contract value, making this one of the largest distribution deals secured by an ASX-listed point-of-care diagnostics company. Even in a less favorable scenario where the CLIA waiver is not granted, the contract retains a minimum value of approximately US$25 million, reflecting a substantial baseline revenue stream.

Strategic Partnership and Market Reach

PHASE Scientific will hold exclusive rights to distribute and commercialize FebriDx® in the US, with plans to co-brand the product under the INDICAID® family, a trusted rapid diagnostics brand. This partnership leverages PHASE’s extensive network of urgent care centers and clinics, positioning FebriDx® for rapid adoption where timely and accurate respiratory infection diagnosis is critical.

Lumos retains all intellectual property rights and manufacturing responsibilities, ensuring quality and regulatory compliance. There is also potential for territorial expansion into China, subject to mutual agreement, which could further amplify the product’s global reach.

Regulatory Progress and Next Steps

The FebriDx® CLIA waiver study is progressing well, with 105 of 120 targeted bacterial positive patients enrolled as of early July. Completion is anticipated by August 2025, with the FDA waiver application expected shortly thereafter. This regulatory milestone is critical, as it will enable FebriDx® to be used in a broader range of outpatient settings, including physician offices and urgent care clinics, significantly expanding its market potential.

Meanwhile, Lumos continues to engage with the Biomedical Advanced Research and Development Authority (BARDA), with a milestone payment of approximately US$746,000 expected upon study completion. The company is also exploring financing options to support its broader growth ambitions.

Outlook and Industry Impact

This agreement marks a transformative moment for Lumos Diagnostics, validating the clinical and commercial value of FebriDx® and positioning the company for accelerated growth in the US. The partnership with PHASE Scientific brings together complementary strengths in innovation, distribution, and market access, setting the stage for FebriDx® to address the urgent global challenge of antimicrobial resistance by reducing unnecessary antibiotic prescriptions.

As the healthcare landscape increasingly demands rapid, reliable diagnostics at the point of care, Lumos’ progress signals a promising future not only for the company but also for improved patient outcomes and healthcare efficiencies.