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Lumos Diagnostics Wins Key U.S. Clearance as FebriDx Drives Strong Quarterly Growth

Story Highlights
  • Lumos secured U.S. 510(k) clearance with a CLIA waiver for FebriDx, vastly expanding its addressable market and reinforcing its position in rapid respiratory infection testing.
  • Third-quarter revenue climbed 37% as FebriDx product sales surged and new funding from milestone payments and a share placement strengthened Lumos’ balance sheet for further growth.
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Lumos Diagnostics Wins Key U.S. Clearance as FebriDx Drives Strong Quarterly Growth

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The latest update is out from Lumos Diagnostics Holdings Ltd. ( (AU:LDX) ).

Lumos Diagnostics reported strong third-quarter FY26 momentum as U.S. regulators granted a 510(k) clearance with a CLIA waiver for its FebriDx test, expanding its addressable U.S. market to about 80 million patients annually and opening access to more than 300,000 testing locations. The broader use of FebriDx, alongside milestone payments tied to this approval and progress in a BARDA-funded paediatric study, significantly enhances Lumos’ revenue potential and deepens its positioning in the acute respiratory infection testing market.

Quarterly unaudited revenue rose 37% year-on-year to US$4.8 million, driven by a 243% surge in product sales to US$2.4 million as FebriDx demand more than offset the discontinuation of the ViraDx test. Service revenue declined 14% on lower recognition of Hologic license income despite ongoing work across 12 projects, while operating cash outflow reached US$2.8 million and the company bolstered liquidity post-quarter with milestone receipts and a A$20 million placement, supporting inventories and continued project development.

Lumos also confirmed that the Hologic fetal fibronectin (fFN) project has moved into Phase 2 with an expanded scope of work, underscoring the importance of its services pipeline as a second revenue pillar. The balance sheet was strengthened after quarter-end by a US$5.0 million milestone payment from PHASE Scientific and the completion of the equity placement, collectively improving the company’s ability to fund growth and commercialise its diagnostics portfolio.

More about Lumos Diagnostics Holdings Ltd.

Lumos Diagnostics Holdings Ltd is an Australia-based leader in rapid point-of-care diagnostic technologies. Its primary products include FebriDx, a rapid fingerstick blood test that differentiates bacterial from non-bacterial acute respiratory infections, with regulatory registrations in the U.S., UK, Europe, Kuwait, UAE and Australia, complemented by a services division delivering diagnostic development projects for third-party clients.

Average Trading Volume: 5,163,082

Technical Sentiment Signal: Buy

Current Market Cap: A$156.9M

For a thorough assessment of LDX stock, go to TipRanks’ Stock Analysis page.

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