Atomo Faces Execution Risks Despite Strong Growth in HIV and Syphilis Testing

Strategic US Supply Agreement

Atomo Diagnostics has taken a significant step forward in commercialising its patented Pascal test cassette with the announcement of a six-year exclusive US distribution agreement for the FebriDx test through its strategic partner Lumos Diagnostics. The FebriDx test, which utilises Atomo’s Pascal cassette, has already secured FDA 510(k) clearance and is nearing completion of a CLIA waiver study expected in August. This regulatory milestone is critical as it would enable broader use of the test in point-of-care settings across the US.

Lumos projects that the PHASE Scientific agreement could generate up to US$316 million in sales over six years, contingent on CLIA waiver approval and minimum order quantities. For Atomo, this translates into anticipated increased demand for its Pascal cassettes, providing a robust revenue stream to support its own diagnostic product development pipeline.

Robust Growth in HIV Self-Test Market

Domestically, Atomo’s HIV Self-Test business has seen remarkable growth, with FY25 sales reaching $1.4 million, more than doubling the previous year’s $575,000. This surge is driven by expanded public health initiatives in Australia, including national vending machine and mail-out programs funded by the Federal Government. Notably, Atomo secured a $450,000 order from the National Association of People with HIV Australia (NAPWHA) and a $230,000 order from Thorne Harbour Health, underpinning the scaling of these programs.

Advances in Syphilis Diagnostics

Atomo’s development of an Active Syphilis rapid test, supported by a $2.44 million government grant, has yielded promising preliminary data. The test demonstrates improved specificity in distinguishing active infections from prior treated cases, a significant clinical advantage over existing antibody-based rapid tests. Given the rising incidence of syphilis in Australia and globally, this innovation could fill a critical gap in point-of-care diagnostics, especially for high-risk populations.

Board Renewal and Financial Position

The company completed a board renewal process, reducing the board size while appointing two new Australian-based directors with extensive experience in in vitro diagnostics and point-of-care testing. This strategic refresh aims to strengthen governance and align leadership with Atomo’s growth ambitions.

Financially, Atomo reported Q4 FY25 revenue of $1.07 million, bringing total revenue and grant income for FY25 to approximately $4.2 million. Operating costs showed a slight quarter-on-quarter increase but declined year-on-year, reflecting operational efficiencies. The company raised about $2.6 million in new capital, primarily from existing shareholders, finishing the quarter debt-free with $3.2 million in cash, positioning it well to fund ongoing business objectives.

Looking Ahead

Atomo’s priorities for FY26/27 include expanding revenues from existing product channels across Australia, New Zealand, Europe, and low- and middle-income countries, commercialising its Active Syphilis test and other Pascal-based diagnostics, and introducing the Florey clip-in test device as a usability upgrade for existing rapid tests. Operational improvements targeting manufacturing efficiencies and cost control are also underway to support sustainable growth.