Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has received a US$5 million milestone pre-payment from its US distribution partner Phase Scientific, with its FebriDx® point-of-care test now moving into broader commercial rollout across the United States.
The payment follows the recent US Food and Drug Administration 510(k) clearance and CLIA waiver for FebriDx®, which satisfies a major milestone under the companies’ distribution agreement.
Importantly, the funds are a pre-payment for future product orders rather than immediate revenue, and will be recognised progressively as purchase orders are fulfilled and units shipped.
The latest instalment brings total pre-payments received from Phase Scientific to US$7.5 million, building on an earlier US$2.5 million received in 2025. These earlier funds have already been applied to initial orders, including a previously announced US$1.3 million purchase — the largest single order for FebriDx to date.
The CLIA waiver significantly expands the addressable market for FebriDx, allowing it to be used in more than 300,000 healthcare settings across the US without the need for complex laboratory infrastructure or specialised training.
This includes primary care clinics, urgent care centres, retail health clinics and community health facilities — a step-change in accessibility that positions the test for widespread frontline use in diagnosing acute respiratory infections.
Lumos noted that FebriDx is already being deployed in certain urgent care networks, including sites operated by WellStreet Urgent Care, where it is used as an initial diagnostic tool for patients presenting with respiratory symptoms.
Chief executive officer Doug Ward said the milestone shows regulatory progress is translating into commercial momentum for Lumos.
“Receipt of the US$5.0 million pre-payment confirms that the 510(k) and associated CLIA waiver have satisfied this critical milestone under the PHASE Agreement,” he said. “We look forward to working closely with PHASE and supporting them as we work together to secure the widespread rollout of FebriDx across the US market.”
The update builds on recent momentum in Lumos’ US rollout strategy for FebriDx, with growing demand and distribution activity following the CLIA waiver expansion.
While the FebriDx pre-payment strengthens Lumos’ near-term cash position, the company emphasised that conversion into revenue will depend on the pace of incoming purchase orders from Phase Scientific — a key indicator of underlying demand.
