Atomo Diagnostics (ASX:AT1) outlined stronger quarterly revenue, continued momentum in its OEM “Pascal” platform, and progress across a growing pipeline of point-of-care tests, according to management’s quarterly presentation and Q&A.
Quarterly financial update and cash position
The company reported quarterly revenue of AUD 1.5 million, which management said was more than double the prior quarter. The increase was described as coming from growth in HIV sales and, primarily, increased OEM revenue tied to Pascal orders from Lumos for its FebriDx product.
Management also highlighted its focus on operating cost control, noting net cash from operating activities was under AUD 1 million of burn across the first half-year to date and that the most recent quarter was cash-flow positive. The company emphasized its strategy of using grant funding and partners’ prior R&D investment to progress products without significantly drawing down Atomo’s cash balance.
Pascal OEM growth tied to Lumos and new customers
Atomo said it continues to see growth in its OEM Pascal business, driven primarily by orders from Lumos related to FebriDx. Management noted Lumos has publicly indicated it expects an FDA CLIA waiver decision “in the coming months,” but Atomo said it would not comment on timing beyond pointing shareholders to Lumos’ disclosures, as Atomo is not the listed manufacturer and is not managing the FDA interaction.
The company also said it has added new OEM customers for Pascal. While Atomo did not name the customers or specify applications due to product confidentiality, it described them as international customers with “novel products.” One customer has purchased what management called a “substantial quantity” of Pascal units to support validation, clinical go-to-market, and regulatory approvals, which Atomo characterized as a significant commitment that it expects to convert into a longer-term supply agreement in the coming months. A second customer, which has already paid development fees for feasibility work, is expected to place an order of similar size for verification/validation and regulatory work, which management said it believes will lead to longer-term supply arrangements similar to existing relationships.
HIV self-test demand and market expansion
Atomo described continued demand for its HIV self-test products, including in Africa. Management specifically referenced a “significant order” from the Global Fund and said it remains focused on supporting that public health market while also driving factory utilization in South Africa.
The company reiterated its view that long-term opportunity in HIV self-testing is being supported by adoption of self-testing and pharmacy retail channels. Management referenced previous progress in Australia and the U.K. (including Boots and Tesco) and said it does not see the transition toward consumer health testing slowing.
In Australia, Atomo said the federal government has committed to funding HIV self-test programs over the longer term, following pilot efforts that the company said it supported alongside program partners to ensure product availability. Management also noted it launched in New Zealand last year and hired a new commercial resource before Christmas, with a mandate to grow HIV sales and support launches in other markets where Atomo does not currently generate revenue. The company highlighted Eastern Europe and Southeast Asia as focus regions.
Syphilis program: clinical planning and trial timing
On its syphilis program, Atomo said it continues to see public health and clinical interest, citing that the Australian government designated syphilis a priority disease last year. Management described syphilis as “out of control” and argued that point-of-care screening options are limited due to deployment challenges and difficulty distinguishing antibody-positive results caused by active infection versus prior treated infection.
Atomo said its test has shown “best-in-class” specificity in preliminary verification and clinical testing in Australia, which management said has resonated with clinicians. The company discussed potential channels including pharmacy retail (leveraging groundwork from HIV) and public health programs, including the possibility of dual screening for HIV and syphilis in overlapping risk cohorts.
Management said it has had positive engagement with regulators and is finalizing go-to-market regulatory and clinical planning. It expects to begin clinical trials for syphilis in the next 3–6 months (before the end of the current financial year). Atomo also said it is conducting a technology transfer from Burnet into an ISO 13485-certified facility to support validated production for sale.
ALT liver function test license with Burnet and early applications
Atomo highlighted a new license agreement with Burnet for an ALT liver function test, describing it as an expansion of a strategic partnership. Management said Burnet developed an ALT assay with sensitivity and specificity intended for measuring liver inflammation, and Atomo has worked for over a year on integrating it onto the Pascal platform. The company said verification and clinical validation work has shown the test performs in the field.
Management clarified that the worldwide license is exclusive within point-of-care testing, covering testing outside laboratories, including hospital clinic wards, CLIA-waived clinics, doctor’s offices, decentralized community screening, and at-home use (prescribed or over-the-counter). The company said its rights cover manufacture and supply across these markets and could include visually read tests, app-read tests, or tests used with a reader.
Atomo said the first targeted application is monitoring drug treatments with known liver toxicity risk. Management noted Burnet previously engaged a large multinational pharmaceutical company for a U.S. clinical trial and that Atomo had previously supplied 20,000 cassettes to Burnet for that purpose. The trial is underway, and Atomo said it expects to use results to help develop the clinical plan for a first-to-market drug-induced liver injury monitoring application. Additional potential use cases discussed included hepatitis monitoring and longer-term screening and monitoring for fatty liver disease and alcohol-related liver disease, though Atomo said further work is needed to determine the best deployment approach for those populations.
When asked about timing for submitting regulatory dossiers for the liver test, management said it needs to review clinical data from the drug-induced liver injury application before providing guidance. It added that future applications may require additional clinical studies because end users and endpoints differ, though the underlying test would remain the same.
Operational expansion to increase capacity
To support anticipated demand, Atomo described an operational upgrade intended to increase manufacturing capacity and improve supply resilience. Management said its validated Mk1 machine in the U.S. supports Lumos and NG Biotech and has also been used for customer R&D. It also discussed “blister machine 2” built in Sydney, previously used for new customer development, which has now been moved into an Atomo facility to be operated directly.
The company said this expansion is expected to scale blister production used in Pascal and other devices and provide dual-source capability. Once validated, Atomo said total capacity could reach about 12 million, potentially up to 15 million units per year, with expected benefits over time including improved cost of goods and reduced lead times. Management said it aims to have products validated and available through the Sydney facility under Atomo’s quality management system by the end of the calendar year.
In closing remarks, management said it expects revenue to continue growing without a corresponding increase in operating costs, and noted that losses have been trending down quarter over quarter. The company said it plans to provide longer-term strategic updates in its upcoming half-year report.
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.
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