Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has received its largest purchase order to date for the FebriDx® rapid respiratory infection test, with US exclusive distributor PHASE Scientific lodging an order valued at US$1.3 million.
The order marks an early commercial outcome from the expanded US opportunity now available to FebriDx.
The order follows the US Food and Drug Administration’s 510(k) clearance and CLIA waiver for FebriDx® on March 27, 2026 — a milestone that opens a market opportunity exceeding US$1 billion and expands the test’s addressable market by around 15 times.
FDA clearance broadens commercial reach
The CLIA waiver is a significant step for Lumos because it allows FebriDx to be used in decentralised healthcare environments such as primary care clinics and outpatient settings, rather than being limited to more complex laboratory settings.
That regulatory outcome materially broadens the product’s addressable market in the US. Lumos has previously said the waiver opens a market opportunity worth more than US$1 billion and expands the addressable market for FebriDx by around 15 times.
The FDA decision followed 510(k) clearance for the test and also triggered US$5.5 million in milestone payments to Lumos, strengthening the company’s position as it moves to scale up US commercial operations.
Fresh capital to support US rollout
Lumos has also moved to bolster its balance sheet, raising $20 million through an institutional placement to support manufacturing scale-up and commercial execution for FebriDx in the US.
The placement was priced at 22.5 cents per share and drew support from new and existing institutional investors. The company is also seeking to raise a further $2 million through a share purchase plan for eligible shareholders in Australia and New Zealand at the same price.
In addition, existing shareholders Tenmile and Ryder Capital have committed to exercise at least 43.9 million options, which is expected to deliver a further $3.1 million in proceeds.
The combined funding is intended to help Lumos meet increasing demand and support broader market penetration following the FDA waiver.