Lumos Diagnostics Holdings Ltd (ASX:LDX), a company specialising in rapid, point-of-care diagnostic test technology, announced it has received its largest purchase order to date for its FebriDx® product. The order, valued at US$1.3 million, comes from PHASE Scientific (“PHASE”), Lumos’ US exclusive distributor. This follows the US FDA’s 510(k) clearance with CLIA waiver for FebriDx® on 27 March 2026.
The recent FDA clearance significantly expands the addressable market for FebriDx®, unlocking a US$1.0+ billion market opportunity representing a 15-fold increase. FebriDx® is a rapid point-of-care test designed to help healthcare professionals more accurately diagnose and manage medical conditions. Lumos also offers customized assay development and manufacturing services for point-of-care tests and proprietary digital reader platforms.
Doug Ward, CEO of Lumos Diagnostics, commented on the announcement, stating that the record order soon after the CLIA waiver is a strong validation of the commercial opportunity for FebriDx® in the US market. He added that the company looks forward to supporting PHASE as it scales its commercial rollout and drives adoption of FebriDx® across a broader range of urgent and primary care settings.
The announcement was approved by the Lumos Disclosure Committee. Lumos Diagnostics specialises in rapid and complete point-of-care diagnostic test technology to help healthcare professionals more accurately diagnose and manage medical conditions. The company offers customized assay development and manufacturing services for point-of-care tests and proprietary digital reader platforms. Lumos also directly develops, manufactures, and commercializes novel Lumos-branded point-of-care tests that target infectious and inflammatory diseases.
