Lumos Diagnostics (ASX: LDX), a company specialising in rapid, point-of-care diagnostic test technology to help healthcare professionals more accurately diagnose and manage medical conditions, has signed a significant six-year exclusive distribution agreement with PHASE Scientific for its FebriDx® product in the United States. The agreement is valued at up to US$317 million (A$487 million), contingent on achieving milestones and minimum order quantities. PHASE Scientific is a biotech company focusing on innovative diagnostics and healthcare solutions headquartered in Hong Kong.
The deal includes an immediate US$2.0 million payment to Lumos, comprising a US$1.0 million exclusivity fee and a US$1.0 million pre-paid purchase order. A further US$1.5 million pre-paid purchase order will become payable upon application to the U.S. Food and Drug Administration (FDA) for a CLIA waiver, expected within the next three months. An additional US$5.0 million, non-refundable, pre-paid purchase commitment is contingent on the granting of the FDA CLIA waiver.
Lumos CEO Doug Ward highlighted the agreement as a pivotal moment for the company, anticipating that it will secure adoption of FebriDx® in the U.S. market. PHASE Scientific CEO Dr. Ricky Chiu expressed enthusiasm for the partnership, noting that FebriDx® is poised to transform rapid respiratory diagnostics. The agreement allows PHASE Scientific to commercialise a co-branded product (INDICAID® FebriDx®) in the U.S.
Lumos is currently conducting a CLIA waiver study to broaden the settings in which FebriDx® can be used. As of July 9th, the study has enrolled 105 of the targeted 120 bacterial positive patients. Completion is expected in August, with the FDA application to follow approximately one month later. Subject to not obtaining the CLIA waiver, the agreement anticipates a contract value of US$25 million over the six-year term.
