In a significant move set to reshape rapid diagnostics in the U.S., ASX-listed Lumos Diagnostics (ASX:LDX) has signed an exclusive six-year distribution agreement with PHASE Scientific, valued at up to US$317 million (A$487 million), for the supply of its flagship test, FebriDx®.

Targeting a High-Growth Market

The deal places Lumos’ FebriDx® at the forefront of the U.S. respiratory diagnostics market, pending CLIA waiver approval from the U.S. Food and Drug Administration (FDA) – a milestone that would allow its use in low-complexity clinical settings like urgent care clinics and GP offices.

“This distribution agreement reflects a pivotal moment in Lumos’ evolution,” said Lumos Diagnostics CEO Doug Ward.
“We look forward to working with the PHASE Scientific team to ensure that FebriDx® secures adoption in the U.S. market, delivering tangible clinical and financial value to the broader healthcare system.”

Upfront Payments and Clear Milestones

The agreement includes immediate and staged, non-refundable payments to Lumos, demonstrating PHASE Scientific’s strong commitment to the success of FebriDx® in the U.S.

An initial US$2.0 million has already been triggered, comprising:

• US$1.0 million exclusivity fee, and
• US$1.0 million pre-paid purchase order.

A further US$1.5 million will be payable on submission of the FebriDx® CLIA waiver application, expected within the next three months. Upon FDA clearance, another US$5.0 million pre-paid purchase commitment will be made.

“This agreement validates the value of the FebriDx® technology and provides a clear pathway to the U.S. market, which we expect will accelerate rapidly, should we secure the CLIA waiver classification from the FDA,” Ward added.

Progress Toward FDA Approval

Lumos has made strong progress toward the regulatory hurdle. As of 9 July, 105 of the required 120 bacterial positive patients have been enrolled in the pivotal CLIA waiver study. The company anticipates completing the study in August, followed closely by submission to the FDA.

The completion of this milestone will also trigger a US$746,143 payment from Lumos’ U.S. partner in the study, Biomedical Advanced Research and Development Authority (BARDA).

High-Confidence Revenue Outlook

Assuming all minimum order quantities (MOQs) and payment milestones are met, the total contract value could reach US$317 million (A$487 million). Even without FDA clearance, the agreement would still yield an estimated US$25 million (A$38 million) over six years, with upfront payments remaining unchanged.

Lumos expects to meet or exceed previously reported gross margins on FebriDx® sales through this agreement.

PHASE Scientific Brings Scale and Reach

PHASE Scientific, based in Hong Kong with U.S. operations in California, will distribute FebriDx® under a co-branded label: INDICAID FebriDx. The company has sold over 100 million INDICAID-branded tests and brings a strong U.S. distribution network, especially in urgent care and outpatient clinics.

“PHASE Scientific is proud to partner with Lumos as their exclusive U.S. distributor for FebriDx®,” said Dr. Ricky Chiu, Founder and CEO of PHASE Scientific. “With strong product differentiation and a CLIA waiver on the horizon, FebriDx® is poised to transform the landscape of rapid respiratory diagnostics and clinical decision-making.”

Leadership Applauds Strategic Momentum

Lumos’ Non-Executive Chairman, Sam Lanyon, also welcomed the deal.
“I want to congratulate our CEO, Doug Ward and the team on today’s pivotal milestone, and to welcome PHASE Scientific as our exclusive U.S. FebriDx® distributor,” Lanyon said.
“We believe FebriDx® is a product that can have a very significant, positive impact on patients’ healthcare outcomes.”

Looking Ahead

While the agreement focuses solely on the U.S. market for now, it includes provisions to potentially expand into China, subject to future negotiations and Lumos’ approval. Lumos retains full control over manufacturing, intellectual property, and regulatory compliance.

As the healthcare industry continues to prioritise speed and accuracy in diagnostics, particularly for respiratory illnesses, this deal represents a critical foothold for Lumos in the world’s largest healthcare market.