Atomo Diagnostics delivers 41% revenue growth in transitional FY26
Atomo Diagnostics delivered total revenue of $5.3 million in its FY26 full-year results for the period ended 30 June 2026, up 41% year-on-year. Management framed the period as a year of transition, laying the foundation for sustainable, diversified growth alongside a leadership handover.
Underlying EBITDA improved 39%, with the loss narrowing from $3.38m to $2.06m. The company finished the year debt free with $3.7m cash on hand.
FY26 snapshot
- Total revenue: $5.3m (+41%)
- Underlying EBITDA: –$2.06m (+39% improvement)
- Cash receipts: $10.2m
- Cash on hand: $3.7m, debt free
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Multiple growth engines power the top line
Revenue growth was broad-based across the business, reducing reliance on any single stream. The HIV franchise grew 21% to $2.8m, while OEM revenue rose 209% to $2.2m, driven by partner Lumos Diagnostics’ launch of the CLIA-waived FebriDx product.
Total revenue also includes development and other income.
| Segment | FY26 | Growth YoY |
|---|---|---|
| HIV | $2.8m | +21% |
| OEM (Pascal) | $2.2m | +209% |
| Total Revenue | $5.3m | +41% |
HIV distribution expands across key markets
Pharmacy onboarding and international demand supported the HIV franchise through FY26. Momentum built across both established and emerging markets:
- Australian pharmacies: 196 active (up from 126), with 59 new pharmacies added in FY26 and a target to grow 6x over the next three years
- New Zealand: 73 pharmacies activated since the FY25 launch, with a target to grow 8x over three years
- NAPWHA government programme demand grew 275% over the last 24 months
- International revenue: NFLD (Europe) up 69%, Viatris (LMIC) up 74%
A new leadership chapter as Atomo scales globally
The results period coincided with a leadership transition, framed by management as a deliberate move from foundation-building to global commercial scale. The change builds on 15 years of innovation and execution under founder and long-standing CEO John Kelly, and marks the next phase of the company’s development.
Dr. Cheri Walker was appointed Interim CEO and Executive Director, bringing extensive experience across life sciences, diagnostics and international commercialisation. The company noted that its leadership is now positioned closer to key growth markets, particularly the US and Europe, as strategic priorities shift toward accelerating adoption and expanding partnerships.
Cheri Walker, CEO, Atomo Diagnostics
“It’s an exciting time to join Atomo as we enter our next phase of growth and continue building a strong pipeline of point-of-care diagnostic products for significant global markets.
We are making good progress with our active syphilis and ALT liver function tests, while also evaluating several additional indications to complement our established HIV products.
Atomo’s all-in-one blood-based testing platform is designed to deliver superior usability and greater consistency of results—an important advantage as we expand our professional-use diagnostics portfolio.”
What Atomo does — the point-of-care diagnostics story
Atomo is a commercial-stage diagnostic company generating revenue from approved professional and self-test point-of-care tests (POCT) sold across global markets. Its solutions are designed to support decentralised testing, a trend accelerated during the pandemic and now driven by evolving global rapid testing requirements.
The business operates through two arms. The first comprises Atomo’s own branded blood-based rapid tests for professional and self-test channels. The second is the OEM business, which supplies its all-in-one Pascal device to partners seeking improved usability and performance for blood-based POCT.
Technical definition: CLIA waiver
A CLIA waiver is a US regulatory approval allowing a test to be used in decentralised settings. According to the company, CLIA waiver approval typically increases the addressable market for a rapid blood test by more than 10-fold.
The FebriDx breakthrough anchors OEM momentum
The most material OEM development in FY26 centred on FebriDx, a rapid blood-based test that differentiates bacterial from non-bacterial infection using Atomo’s Pascal device. The following points detail the milestone:
- FY26 FebriDx orders totalled ~A$1.9m, a nine-fold increase on FY25.
- Partner Lumos Diagnostics received a US FDA CLIA waiver for FebriDx, based on Pascal performance validated in US trials at greater than 99% concordance between trained and untrained users.
- Lumos signed a six-year agreement with PHASE Scientific for US supply, and anticipates FebriDx revenues of up to US$317 million over the term, assuming the CLIA waiver is granted and contracted minimum order quantities (MOQs) are achieved.
- Every FebriDx test sold to PHASE requires Lumos to order a Pascal cassette, with Atomo receiving a percentage of proceeds based on the Pascal transfer price.
The FDA CLIA waiver for FebriDx, confirmed in March 2026, formally activated US$3.4 million in committed Pascal revenues under the exclusive Lumos supply agreement and expanded the US addressable market by approximately 15 times by enabling deployment in pharmacies, urgent care clinics, and physician offices without certified laboratory personnel.
For investors, this arrangement creates recurring, volume-linked revenue tied to a large US commercial rollout, contingent on the disclosed regulatory and contractual conditions being met.
Emerging OEM partnerships broaden the pipeline
Beyond FebriDx, Atomo advanced two additional OEM partnerships during FY26:
- Chromacare (Canada): a rapid test measuring iron levels (Ferritin) for professional and self-test markets, with an initial order of ~A$170,000 received this year and a long-term Pascal supply agreement anticipated in early FY27
- UK customer: a novel rapid test addressing a large unmet clinical need in professional settings, with 20,000 Pascal units ordered to support validation and a commercial supply agreement anticipated in early FY27
Own product pipeline expands addressable markets
Two internal products advanced during the period, creating future optionality for the portfolio.
For active syphilis, product development was completed, with clinical trials commencing early CY27. The company noted that no existing rapid test can reliably distinguish active from prior infection, and reported sensitivity greater than 85% for active syphilis detection, which it described as market-leading. The product leverages existing HIV distribution channels for a faster, lower-cost route to market, supported by non-dilutive CRC-P grant funding.
The ALT liver test completed test development, with go-to-market development commenced. Applications include drug-induced liver injury (DILI) monitoring and fatty liver disease screening, the latter affecting more than 1.5 billion people globally. The company cited a DILI serviceable obtainable market growing from A$72m in 2025 to A$100m by 2032, and a fatty liver screening market of A$80m by 2032.
The exclusive global liver test licence secured through 2044, which includes a 20,000-cassette pharmaceutical company validation order already underway in a US drug trial, underpins the commercial credibility of the ALT pipeline asset and reduces technical risk ahead of the go-to-market phase.
Financial position — improving economics, debt-free balance sheet
Revenue rose 41% to $5.33m, driven by strong volume demand across the HIV Global Health market. Gross margin declined to 35% from 51%, reflecting a product mix shift toward higher-volume, lower-yielding Global Health segments. The prior year also included approximately $340k in one-off licence fees.
Underlying EBITDA improved 39%, with the loss narrowing from $3.38m to $2.06m. Operating expenses reduced year-on-year while the company continued to invest in research and development.
| AUD | FY26 ($m) | FY25 ($m) | (%) |
|---|---|---|---|
| Revenue | 5.33 | 3.79 | 41% |
| Gross Profit | 1.88 | 1.92 | (2%) |
| Gross Margin | 35% | 51% | — |
| Underlying EBITDA | (2.06) | (3.38) | 39% |
Cash and balance sheet strength
Total cash receipts of $10.2m comprised approximately $4.6m in customer receipts, $875k from the R&D tax rebate, $660k from the CRC-P grant, and approximately $4.0m from capital raised during the period, net of transaction costs.
The company ended the year with $3.7m in cash and remained debt free. Net assets increased to $7.71m from $6.97m. Management noted the capital raise of $4.0m net supports ongoing commercialisation and pipeline development.
The road ahead — a compounding growth thesis
Management stated it expects the underlying revenue trajectory to continue into FY27 and beyond, supported by multiple complementary growth engines across HIV, OEM/Pascal and emerging diagnostic opportunities.
Operational upgrades, including qualification of a second-generation Blister Machine and high-cavitation mould tooling, target improved margins and expanded capacity. As revenue scales, the company expects it to cover most non-research operating costs, providing the opportunity to selectively reinvest in R&D and product development.
The company summarised its investment case as a compounding cycle: revenue growth leads to improved operating leverage, enabling reinvestment in R&D, a broader product portfolio, and longer-term revenue growth and enterprise value.
Atomo Diagnostics will host its Strategy Update and FY26 Full Year Investor Webinar on Thursday 24 September 2026, with registration and access details to be released to the ASX in due course.
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