Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has secured a landmark six-year exclusive distribution agreement worth up to US$317 million (A$487 million) with PHASE Scientific for its FebriDx® rapid point-of-care test in the United States, pending a Clinical Laboratory Improvement Amendments (CLIA) waiver from the United States Food and Drug Administration (FDA).
This marks a major inflection point in Lumos’ commercial trajectory and stands as one of the largest distribution deals executed by an ASX-listed point-of-care diagnostics company.
The agreement includes an immediate US$2 million commitment comprising a US$1 million exclusivity fee and a US$1 million pre-paid purchase order, with a further US$6.5 million payable contingent on progress with the CLIA waiver. If the waiver is granted, the agreement opens a high-growth channel for FebriDx® across a wide network of US healthcare providers.
“This distribution agreement reflects a pivotal moment in Lumos’ evolution. We look forward to working with the PHASE Scientific team to ensure that FebriDx® secures adoption in the US market, delivering tangible clinical and financial value to the broader healthcare system,” Lumos CEO Doug Ward said.
“This agreement validates the value of the FebriDx® technology and provides a clear pathway to the US market, which we expect will accelerate rapidly, should we secure the CLIA waiver classification from the FDA.”
Strategic alignment and commercial opportunity
The deal positions FebriDx® within PHASE Scientific’s INDICAID® product family — a brand that has delivered over 100 million rapid tests globally. PHASE’s established US presence and commercial infrastructure offer Lumos a robust pathway to scale FebriDx®’s adoption and revenue growth.
PHASE Scientific CEO Dr Ricky Chiu said FebriDx® “is poised to transform the landscape of rapid respiratory diagnostics”.
Breakdown of agreement terms and structure
Under the terms of the agreement, PHASE Scientific has secured exclusive rights to distribute and commercialise FebriDx® in the US over an initial six-year term, with provisions for extension. The total contract value of US$317 million hinges on PHASE meeting defined minimum order quantities (MOQs) and payment milestones, including:
- US$1 million non-refundable exclusivity fee and US$1 million pre-paid purchase order on signing;
- US$1.5 million additional purchase order upon FDA CLIA waiver application submission;
- US$5 million non-refundable commitment upon CLIA waiver approval.
In the absence of a CLIA waiver, MOQs reduce to 7% of the original schedule, resulting in a reduced potential contract value of US$25 million (A$38 million). Lumos will retain manufacturing rights and all intellectual property.
Chiu noted: “PHASE Scientific is proud to partner with Lumos as their exclusive US distributor for FebriDx®, and to welcome it into our INDICAID® family — our trusted rapid diagnostics brand known for accessibility and quality. 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. Backed by PHASE’s record of having sold over 100 million INDICAID tests and a nationwide network of urgent care centres and clinics, we’re uniquely positioned to bring this innovation to the frontlines of care — where speed, accuracy, and reliability matter most.”
Progress on CLIA waiver study and next steps
Lumos is nearing completion of its CLIA waiver clinical study, designed to broaden FebriDx®’s eligibility for use in low-complexity healthcare settings such as US physician offices and urgent care centres.
As at July 9, 105 of the required 120 bacterial-positive patients had been enrolled, with study completion anticipated in August and submission of the CLIA waiver application expected within one month thereafter.
A milestone payment of US$746,143 from Lumos' partner, the Biomedical Advanced Research and Development Authority (BARDA), will be triggered upon enrolment of the final patient.
“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,” Lumos’ non-executive chairman Sam Lanyon said.
“We believe FebriDx® is a product that can have a very significant, positive impact on patients’ healthcare outcomes, and are delighted to see the US commercialisation and distribution of FebriDx® in the hands of a highly supportive and motivated partner.
“Looking beyond our FebriDx® strategy, I am proud of the considerable progress that the Lumos team continues to make in broadening its product range, services and commercial partnerships.”
Outlook and broader Lumos strategy
Lumos remains focused on expanding its proprietary point-of-care test portfolio and strategic commercial partnerships. The company continues to progress its development of new products and partnerships, reinforcing the longer-term growth agenda beyond FebriDx®.
While Lumos is engaged in financing discussions, these remain at an early stage and have not yet reached sufficient certainty to disclose further.
About PHASE Scientific
PHASE Scientific International Limited is a rapidly expanding biotechnology company dedicated to improving health through innovative diagnostics and healthcare solutions. With operations in the US, mainland China, and Hong Kong SAR, PHASE Scientific provides advanced diagnostic tools and services for cancer and infectious diseases, utilising proprietary technologies to enhance disease detection, diagnosis, and management.
Its products and services have received certifications from regulatory agencies including the US FDA and the European Union CE, and it has supplied over 100 million testing products and services across more than 30 countries globally. PHASE Scientific recently completed a US$34 million Series A funding round, marking the largest Series A raise in Asia's diagnostic technology sector since 2019. Notable supporters include the Gates Foundation and US governmental agencies like the National Science Foundation and National Institute of Health.
About FebriDx®
FebriDx® is a unique and rapid point-of-care test designed to help clinicians differentiate between bacterial and non-bacterial acute respiratory infections. It uses a simple fingerstick blood sample and provides results in approximately 10 minutes.
By enabling faster and better decision-making at the point-of-care, FebriDx has the potential to improve patient outcomes, reduce unnecessary antibiotic prescriptions, and lower overall healthcare costs, while also addressing the global challenge of antimicrobial resistance (AMR). Lumos Diagnostics has also been in discussions regarding a financing agreement, which is currently not sufficiently certain.