Lumos Diagnostics Accelerates Growth with 71% Revenue Surge and BARDA Partnership

Strong Revenue Growth and Capital Raise

Lumos Diagnostics (ASX: LDX) has delivered a compelling second quarter for FY25, reporting unaudited revenue of US$2.9 million, a 71% increase compared to the prior corresponding period. This growth was underpinned by a remarkable 200% surge in product revenue, primarily driven by ViraDx sales in the US, complemented by contributions from FebriDx and Binx products. Services revenue also rose 53%, reflecting ongoing contract manufacturing and development agreements.

In October 2024, Lumos successfully completed the retail entitlement component of a A$10 million capital raise, securing A$6.9 million. This was strongly supported by new and existing investors, including Tenmile and Ryder Capital, bolstering the company’s balance sheet to support upcoming clinical and commercial initiatives.

Strategic Partnership with BARDA Advances FebriDx

A pivotal highlight was Lumos’ partnership with the US Biomedical Advanced Research and Development Authority (BARDA), which awarded the company US$3 million in non-dilutive funding to support the FebriDx CLIA waiver trial and FDA application. This funding, with options to expand to US$8.3 million, underscores the strategic importance of FebriDx as a rapid, point-of-care diagnostic test for bacterial respiratory infections.

The CLIA waiver study commenced in December 2024, with the first patient tested, marking a critical step toward expanding FebriDx’s use in outpatient settings such as physician offices and urgent care clinics. Lumos anticipates completing the study by spring 2025, aiming to unlock a US market opportunity potentially 15 times larger than current addressable segments.

Regulatory and Reimbursement Milestones

In December 2024, Lumos secured CPT Proprietary Laboratory Analyses (PLA) code approval for FebriDx, establishing a reimbursement rate of US$41.38 per test. This approval is a crucial milestone, facilitating broader adoption by enabling reimbursement from government and private insurers. Lumos is actively engaging with payers to finalize coverage policies, a process expected to enhance test accessibility and market penetration.

Operational Progress and Financial Position

On the operational front, Lumos continues to advance its development services, notably the Hologic fFN diagnostic product collaboration. Despite some project timeline extensions, the partnership remains on track with milestone payments expected through 2025. Additionally, Lumos has progressed manufacturing and customization for the Burnet Diagnostics Initiative’s liver function test, with clinical trials slated to begin in early 2025.

Financially, Lumos reported an operating cash outflow of US$3.7 million for the quarter, reflecting increased investment in clinical trials, medical affairs, and working capital ahead of the US flu season. The company ended the quarter with a cash balance of US$5.5 million, which increased to a proforma US$6.4 million following BARDA milestone payments received in January 2025.

Looking Ahead

CEO Doug Ward emphasized the significance of these developments, noting that reimbursement approval and BARDA support lay a strong foundation for FebriDx’s commercial expansion. The company is also focused on progressing the Hologic collaboration and initiating new women’s health diagnostic products. With a strengthened balance sheet and a robust project pipeline, Lumos is positioned for sustained growth in the competitive point-of-care diagnostics market.