Lumos Diagnostics (ASX:LDX) announced a US market expansion triggered by the US FDA granting a CLIA waiver for its flagship point-of-care test, FebriDx.
The regulatory milestone broadens the test's applicability, allowing it to be used in over 300,000 US locations, including primary care offices, urgent care clinics, and retail pharmacies.
The waiver effectively unlocks a market opportunity exceeding US$1 billion, representing a 15-fold expansion for the product.
The Melbourne-based company has secured $20 million through a heavily oversubscribed institutional placement.
In addition to the placement, Lumos announced a share purchase plan to raise an additional $2 million, providing retail shareholders an opportunity to participate in the growth phase.
Further financial stability is bolstered by existing shareholders, Tenmile and Ryder Capital, who have committed to exercising options worth $3.1 million.
Beyond capital raising, the FDA milestone has triggered immediate windfall payments. Lumos is set to receive US$5.5 million in milestone payments from partners PHASE Scientific and the Biomedical Advanced Research and Development Authority.
The combined funds are earmarked to scale manufacturing capacity and accelerate the commercial rollout of FebriDx across the United States.