Lumos Diagnostics Shares Surge 155% on Landmark AUD 487 Million FebriDx® U.S. Distribution Deal

Sonal Goyal

16 July 2025 12:08 PM AEST

Lumos Diagnostics Shares Surge 155% on Landmark AUD 487 Million FebriDx® U.S. Distribution Deal

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Highlights

Lumos Diagnostics signs six-year exclusive distribution agreement with PHASE Scientific valued up to AUD 487 million (USD 317 million) for FebriDx® in the U.S., pending FDA CLIA waiver.

The agreement includes USD 7.5 million in upfront non-refundable payments, with milestone-based commitments.

LDX shares jumped 155% to 7.4 cents per share on 16 July 2025 following the announcement.

Lumos Diagnostics (ASX:LDX) soared 155% to 7.4 cents per share in morning trading on 16 July 2025, after the company announced a landmark U.S. distribution and supply agreement for its flagship diagnostic product FebriDx®. The agreement, signed with PHASE Scientific International Limited, is valued at up to USD 317 million (AUD 487 million) over six years, marking one of the most significant deals for an ASX-listed point-of-care diagnostics company.

Under the terms of the deal, PHASE Scientific will hold exclusive U.S. distribution rights for FebriDx®, a rapid point-of-care test designed to differentiate between bacterial and viral respiratory infections. The contract is structured around a series of milestone-based non-refundable payments and minimum order quantity (MOQ) commitments, with the potential to unlock full contract value pending U.S. FDA CLIA waiver approval for FebriDx®.

Milestone-Based Payments and FDA Pathway

The agreement includes USD 7.5 million in initial non-refundable payments, comprising:

USD 1.0 million exclusivity fee on signing;
USD 1.0 million initial purchase order on signing;
USD 1.5 million purchase order on submission of the CLIA waiver application to the FDA;
An additional USD 5.0 million purchase commitment will be triggered upon FDA CLIA waiver approval.

Assuming the waiver is granted and MOQ targets are met, the full AUD 487 million contract value will be realised over six years. In the event the CLIA waiver is not obtained, Lumos will still retain USD 25 million (AUD 38 million) in contract value based on reduced MOQ targets.

Lumos has enrolled 105 of the required 120 bacterial-positive patients in its ongoing CLIA waiver study as of 9 July 2025, with study completion expected in August. The FDA application is anticipated to be submitted approximately one month after study conclusion. A milestone payment of USD 746,143 from the Biomedical Advanced Research and Development Authority (BARDA) will be triggered upon enrolment of the final patient.

PHASE Scientific and Market Impact

PHASE Scientific, a global biotech company with operations across the U.S., Hong Kong, and mainland China, will integrate FebriDx® into its INDICAID® rapid diagnostics brand. PHASE has delivered over 100 million diagnostic tests worldwide and has recently completed a USD 34 million Series A funding round, backed by global institutions including the Gates Foundation and U.S. health agencies.

Under the agreement, FebriDx® will continue to be manufactured by Lumos, which retains all intellectual property rights and quality control responsibilities. The product will be distributed in the U.S. as a co-branded solution (INDICAID® FebriDx®), with a potential expansion into the Chinese market subject to Lumos’ approval and further negotiation.

Product Potential and Strategic Outlook

FebriDx® is a 10-minute fingerstick blood test designed to help clinicians quickly distinguish between bacterial and non-bacterial respiratory infections. The test supports better prescribing decisions, reduces unnecessary antibiotic use, and offers a timely solution in the fight against antimicrobial resistance (AMR).

Lumos’ leadership views the PHASE agreement as a major step forward in the commercialisation of FebriDx® in the U.S., with expectations of achieving or exceeding previously reported gross margins on sales. The company also noted that discussions on separate financing initiatives are ongoing but remain insufficiently certain to announce at this stage.

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