Lumos Diagnostics (ASX: LDX), a company specialising in rapid, point-of-care diagnostic technologies, has announced a six-year exclusive distribution agreement with PHASE Scientific for its FebriDx® product in the United States. The deal is valued at up to US$317 million (A$487 million), subject to obtaining a CLIA waiver. PHASE Scientific International Limited is a biotech company focused on innovative diagnostics and healthcare solutions, headquartered in Hong Kong with operations in the U.S. and mainland China.
The agreement includes an immediate payment of US$2.0 million to Lumos, comprising a US$1.0 million exclusivity fee and a US$1.0 million pre-paid purchase order. An additional US$1.5 million pre-paid purchase order will be payable upon submission of the FebriDx® CLIA waiver application to the U.S. Food and Drug Administration (FDA), expected within the next three months. A further US$5.0 million non-refundable, pre-paid purchase commitment is contingent upon the granting of the FDA CLIA waiver.
Lumos CEO Doug Ward highlighted the agreement as a pivotal moment for the company, expressing confidence in PHASE Scientific’s ability to drive adoption of FebriDx® in the U.S. market. PHASE Scientific’s Founder and CEO, Dr. Ricky Chiu, noted the partnership aligns with their mission to deliver accessible and high-quality rapid diagnostics, anticipating FebriDx® will transform respiratory diagnostics with its strong product differentiation. Lumos is currently conducting a CLIA waiver study, having enrolled 105 of the targeted 120 bacterial positive patients as of 9 July, with completion anticipated in August.
Non-Executive Chairman, Sam Lanyon, congratulated the team on the milestone, emphasizing FebriDx®’s potential positive impact on patient outcomes. The agreement terms also allow for potential expansion into China, subject to Lumos’ approval and further negotiation. Lumos will retain all intellectual property rights and remain the manufacturer of FebriDx®, ensuring quality control and regulatory compliance. Lumos expects to meet or exceed the previously reported gross margin of Lumos’ revenue on FebriDx sales.
