Atomo Diagnostics (ASX:AT1) outlined continued revenue growth, improving operating performance, and expanding partner activity around its Pascal cassette platform during its half-year update, while also highlighting progress across its HIV self-testing business and a growing development pipeline that includes syphilis and liver-function testing.
Half-year performance and financial position
Management reported revenue of just under AUD 2.2 million for the half year, representing a 6% increase. Gross profit was AUD 850,000, with management noting a 6% reduction in gross margin largely driven by mix. The company said the prior-year period included development and license fees that carried “extremely high margins,” and that excluding those items, product revenue margin was stable at 37% period over period.
Other income doubled to AUD 1 million, which management attributed primarily to the company’s R&D rebate and non-dilutive funding tied to the Syphilis Development Grant Program. Those funds offset costs incurred during the period, particularly employee and R&D expenses.
On expenses, the company emphasized “disciplined cost management,” highlighting reductions in employee expenses and professional fees that were said to have halved. Underlying EBITDA loss came in under AUD 1 million for the half year, which management described as roughly half the prior level and part of a multi-period trend of narrowing losses since FY2024.
At period end (31 December), Atomo reported AUD 3.5 million in cash and no debt. On cash flow, management said average monthly cash burn, excluding capital funding, was under AUD 170,000 per month, compared with roughly AUD 130,000 in the prior period. The increase was attributed to additional resources directed toward building pipeline opportunities and near- to medium-term revenue streams.
Receipts totaled AUD 4.5 million, which management broke down as AUD 2 million from customers, AUD 875,000 from the R&D rebate, AUD 330,000 from a CRC-P grant, and AUD 1.3 million from a capital raise received in Q1. Total outflows were reported at AUD 4.2 million for stock and operating expenses.
HIV self-testing remains the core revenue stream
Management said the company’s largest revenue contributor continues to be HIV self-testing, citing more than AUD 1 million in HIV sales during the half. Atomo also said it received an additional AUD 1.6 million in orders early in the second half.
The company attributed longer-term opportunity in HIV self-testing to shifts in consumer expectations around at-home testing and public-health recognition that home testing can be a cost-effective way to reach target populations. The company also noted that the Australian Government extended funding for programs Atomo said it helped establish, validate, and scale with community partners.
Looking forward, management said it added commercial resources with a dual focus: increasing sales in existing markets (with emphasis on Australia and New Zealand) and expanding distribution outside Europe, particularly into South America and Asia. The company said it expects to announce new distribution partner opportunities over coming quarters.
Pascal platform momentum: FebriDx orders and new partners
Atomo highlighted increased activity for its Pascal platform, including AUD 1.5 million in orders linked to FebriDx during the half. Management described that as a 1,600% increase versus orders received for the same product in the comparable half-year period 12 months earlier.
The company referenced Lumos’ announcement that the FebriDx U.S. CLIA waiver study met its endpoints, adding that Pascal contributed to usability outcomes in the study, including greater than 99% concordance between trained and untrained users. Management said that usability validation is expected to support the CLIA waiver process, and noted a CLIA waiver decision is pending “in the next couple of months.”
Atomo also sought to clarify the commercial relationship, stating that each FebriDx test sold requires a Pascal device on a one-for-one basis.
Beyond FebriDx, management said the disclosed performance has helped attract additional partners. Atomo said Chromacare, a Canadian company, and an unnamed U.K. company have signed onto the Pascal platform, with the company aiming to finalize longer-term supply agreements in Q4.
- Chromacare: Management said the partner placed an order of more than AUD 150,000 for devices and development support, including 43,000 cassettes to support clinical and regulatory validation. Atomo said it intends to convert the relationship into a long-term exclusive supply agreement in coming months. Management also noted Chromacare’s interest in the U.S. market and the potential to leverage CLIA-waiver-related usability validation.
- U.K. partner: Atomo said the partner signed up for 20,000 cassettes, but the company is not disclosing the customer or application due to commercial confidentiality and what management described as the size of the opportunity.
Management said it is preparing a broader awareness push—particularly in the U.S.—through partnership opportunities, co-promotions, conference representation, and other outreach focused on the value of CLIA waiver for potential customers.
Product pipeline: syphilis and ALT liver function testing
Atomo discussed progress on an active syphilis test it believes could address a growing clinical need. Management cited rising syphilis rates and called it a market opportunity exceeding $1 billion in value, noting the U.K. performed nearly 2 million syphilis tests in 2024, including about 350,000 via at-home dried blood spot collection mailed to labs. The company argued that approach is costly and requires multiple lab tests.
Atomo said its syphilis test correlates highly with RPR testing and is designed to distinguish prior treated cases from active cases—something it said standard antibody tests used in at-home programs do not do well. Management reported preliminary clinical verification work conducted by Burnet showing 86% specificity, and said it hopes to achieve over 90% specificity in the final product. The company also said it is working with partners, including NAPWHA, to integrate the future syphilis test into existing HIV distribution channels such as vending-machine and mail-out programs.
The company also discussed an expanded partnership with Burnet to license and commercialize an ALT liver function test developed on Pascal. Management said the assay has already been evaluated in a clinical study with a pharmaceutical company, and described data showing correlation between fingerstick blood results and lab-generated whole blood. The company said early performance data supports distinguishing a 40 IU cutoff used in screening programs. Atomo identified drug-induced liver injury as the first targeted market, describing potential value for pharmaceutical partners in streamlining trials and managing liver-toxicity risk, while also noting other potential applications including hepatitis B treatment monitoring and fatty liver disease screening and monitoring.
Operational scale-up aimed at capacity and margin improvement
To support expected demand growth, Atomo said it has been expanding operational capabilities since late last year. Management said this work is intended to increase capacity, improve margins by bringing steps in-house and moving to larger multi-cavity tooling, improve process control under the company’s quality management system, and reduce order lead times.
The company highlighted two near-term operational steps: qualification of a high-cavitation injection molding tool and qualification of a second blister machine (“Blister Machine-mk2”) built in Australia and qualified at a Sydney facility. Management emphasized that both assets are already built and paid for, with no additional capital expenditure required to make them operational, and said the changes will support Pascal customers as well as Atomo’s own blister needs for syphilis and liver testing.
In Q&A, management said U.S. HIV self-testing remains a PMA pathway, which it described as expensive, and noted ongoing discussion about potential down-classification to 510(k) that has not yet occurred for self-testing. The company also discussed prototype progress on additional device concepts (Curie and Florey), saying it intends to advance those platforms with partners willing to fund development tied to specific finished-test applications.
About Atomo Diagnostics (ASX:AT1)
Atomo Diagnostics Limited engages in the development and sale of medical devices worldwide. It offers rapid diagnostic test devices for HIV screening, pregnancy test, and respiratory test. Atomo Diagnostics Limited was incorporated in 2010 and is headquartered in Leichhardt, Australia.
