Atomo Diagnostics Halves Losses as Pascal Orders Surge 1,600% in H1 FY26

Atomo Diagnostics delivers Pascal orders surge and halves losses in H1 FY26

Atomo Diagnostics has reported a substantial improvement in its H1 FY26 financial performance, with Atomo Diagnostics Pascal Technology Growth driving a ~1,600% increase in FebriDx orders and underlying EBITDA losses halved to approximately $1 million. The biotechnology company’s results presentation, released 26 February 2026, demonstrates accelerating commercial traction for its proprietary Pascal OEM cassette platform whilst maintaining organic growth in its core HIV self-test business. The company remains debt-free with $3.51 million cash on hand.

Total revenue for the period reached $2.18 million, up 6% on H1 FY25. Cash receipts totalled $2 million from customers, supplemented by $1.2 million in grants and incentives. Underlying EBITDA loss improved 49% to approximately $1 million, down from ~$1.94 million in the prior comparable period. The combination of revenue diversification, cost discipline and materially reduced losses demonstrates a credible pathway toward breakeven.

What is Pascal technology and why does it matter?

Pascal represents Atomo’s proprietary rapid test cassette platform supplied to OEM partners requiring enhanced usability and precision at the point of care. The technology functions as an integrated cassette enabling reliable blood or swab-based testing in professional and self-test settings. Pascal cassettes are custom-manufactured for partners seeking improved performance over standard point-of-care formats.

The platform’s key differentiator lies in its validated usability performance. US clinical studies have demonstrated greater than 99% concordance between trained and untrained users, a critical benchmark for regulatory approvals. This performance characteristic positions Pascal to support CLIA waiver submissions in the United States, where waiver approval typically expands the addressable market for a rapid blood test by more than 10-fold.

Pascal positions Atomo as an enabling technology supplier rather than solely a finished test manufacturer. Each test sold by an OEM partner incorporating Pascal cassettes generates recurring revenue for Atomo, creating operational leverage as partners scale their commercial activities.

FebriDx partnership drives Pascal revenue momentum

H1 FY26 Pascal orders for FebriDx totalled approximately $1.5 million, representing ~1,600% growth compared to H1 FY25. The commercial structure involves Lumos Diagnostics supplying FebriDx (a rapid infection test distinguishing bacterial from viral infections) to PHASE Scientific for the US market. Each FebriDx test sold requires a Pascal cassette from Atomo, establishing a direct revenue linkage.

Pascal FebriDx Order Growth

H1 FY26 orders of ~$1.5 million represent a ~1,600% increase compared to the prior corresponding period.

Lumos Diagnostics has signed a six-year supply agreement with PHASE Scientific, anticipating FebriDx product revenues of up to US$313 million over the term. This revenue projection assumes CLIA waiver is granted and contracted minimum order quantities are achieved. FebriDx has been submitted to the US FDA for CLIA waiver consideration, with a decision anticipated in Q3 FY26. Pascal’s validated usability performance underpins the CLIA waiver submission.

A positive CLIA waiver decision would represent a material catalyst, potentially unlocking substantial recurring Pascal revenue as FebriDx scales across expanded US point-of-care channels. Atomo receives a percentage of the transfer price for each Pascal cassette supplied to support FebriDx sales.

New Pascal customers broaden the OEM pipeline

Atomo secured two new Pascal customers during H1 FY26, diversifying its technology revenue base beyond FebriDx. Chromacare, a Canadian company developing a rapid iron deficiency test, placed an initial order for 43,000 Pascal cassettes generating approximately $170,000 in revenue and development fees. The test targets both professional and at-home self-test markets. A commercial supply agreement is anticipated in Q4 FY26. Chromacare has expressed interest in pursuing US CLIA waiver approval using FebriDx as a predicate device, subject to FebriDx securing waiver status.

A UK-based company developing a stroke detection test ordered 20,000 Pascal cassettes to support validation and registration requirements. The application addresses a clinical need in professional healthcare settings. A commercial supply agreement is similarly anticipated in Q4 FY26.

Atomo is actively engaging US test development companies to promote Pascal as a proven solution for CLIA waiver submissions and self-test applications. Customer diversification reduces reliance on any single partner and demonstrates Pascal’s applicability across multiple diagnostic categories.

Liver test licence opens new addressable markets

Atomo secured an exclusive worldwide licence from Burnet Institute to commercialise a rapid ALT liver function test using the Pascal platform. The test provides point-of-care detection of liver injury through measurement of alanine aminotransferase (ALT), a key indicator of liver inflammation and damage. Product development is substantively complete, with diagnostic performance established in validation studies.

The test demonstrates an R² correlation of 0.9089 between fingerprick and venous blood samples, indicating strong consistency across collection methods. ROC curve analysis using a 40 IU/L threshold yielded an AUC of 0.94, reflecting strong accuracy in distinguishing normal from abnormal ALT levels.

The first commercial application targets monitoring for drug-induced liver injury (DILI) in patients taking medications with known liver toxicity risk. A large multinational pharmaceutical company is already evaluating the test for this purpose in a US drug trial commenced in 2025. This provides a de-risked development pathway with near-term validation milestones.

The broader market opportunity spans four application areas:

1. Drug-induced liver injury monitoring (TB drugs, immunology medications including Methotrexate, Leflunomide and Azathioprine, cardiovascular drugs such as Amiodarone, neurology treatments including Valproate, and long-term analgesic use)
2. Hepatitis B and C diagnosis and treatment management
3. Fatty liver disease screening (affecting more than 1.5 billion people globally)
4. Alcoholic liver disease screening (affecting approximately 300 million people globally)

The de-risked development pathway and pharmaceutical evaluation provide near-term validation milestones, whilst the broad commercial utility across multiple high-prevalence conditions creates long-term optionality for revenue generation.

HIV self-test business sustains organic growth

Atomo’s HIV self-test business generated $1.1 million in H1 FY26 revenues, with a further ~$1.6 million in orders received during Q3 FY26. The HIV business provides stable revenue underpinning operations whilst OEM and new test revenues scale. The Australian federal government has reaffirmed continued funding for Australia’s key HIV self-test distribution programmes, supporting revenue visibility.

Atomo has secured an experienced commercial resource focused on expanding Australian revenues and establishing international channel partnerships, with initial focus on Europe and Asia. The global HIV rapid test market is estimated at US$1.75 billion, growing at a 10% CAGR. Self-testing adoption is accelerating, driven by privacy, convenience and growing procurement of self-tests by public health bodies.

Recurring government-supported distribution programmes provide revenue visibility, whilst self-testing adoption trends support long-term market growth. The HIV business demonstrates Atomo’s capability in commercialising finished diagnostic tests alongside its Pascal OEM platform.

Active Syphilis test addresses unmet clinical need

Atomo’s Active Syphilis test addresses a clinical gap in sexually transmitted infection diagnostics. No rapid test currently available can reliably distinguish active syphilis infection from prior treated infections at the point of care. This limitation complicates clinical decision-making and treatment protocols.

Atomo’s test has demonstrated 86% specificity in distinguishing active infections, compared to less than 45% for current rapid tests on the market. Product development is complete, with preliminary verification supporting best-in-class diagnostic performance. Preliminary engagement with clinicians, regulators and public health bodies has been positive. Clinical trials are anticipated to commence mid-year 2026.

The global syphilis testing market was valued at US$1.1 billion in 2020 and is projected to reach US$1.9 billion by 2030. Data suggests the UK performed approximately 1.8 million syphilis tests in 2024, including ~350,000 tests supported through at-home blood sample collection with mail-to-laboratory confirmation.

Best-in-class diagnostic performance positions Atomo to capture market share in a segment with strong public health tailwinds, particularly as testing volumes increase and self-testing adoption expands.

Financial position supports pathway to profitability

Atomo reported a cash balance of $3.51 million at 31 December 2025, up from $3.22 million at FY25. The company remains debt-free. Total assets stood at $9.48 million, with net assets of $6.64 million. Operating expenditure remained stable during H1 FY26, supported by cost-saving initiatives.

Underlying EBITDA loss halved to approximately $1 million, down 49% from ~$1.94 million in H1 FY25. The improvement reflects disciplined cost management combined with revenue growth across the Pascal platform and HIV business.

Total cash receipts for H1 FY26 comprised:

• ~$2 million from product sales
• $875,000 from R&D tax rebate
• ~$330,000 from CRC-P Grant supporting Active Syphilis test development
• ~$1.3 million from capital raising in July 2025 (net of transaction costs)

Non-dilutive funding from grants and R&D tax rebates supports product development activities, reducing operating expenditure requirements whilst maintaining investment in pipeline assets.

The halving of losses combined with multiple near-term revenue catalysts (FebriDx CLIA waiver decision, new Pascal commercial agreements, clinical trial commencements for Active Syphilis and liver test evaluations) provides a credible trajectory toward operating cash flow breakeven.

Catalysts and outlook

Atomo Diagnostics (ASX: AT1) has established a diversified revenue model combining Pascal OEM technology with proprietary diagnostic tests. Multiple de-risking milestones across the next two quarters provide opportunities for valuation re-rating if successfully achieved:

1. Q3 FY26: US FDA decision on FebriDx CLIA waiver anticipated
2. Q4 FY26: Commercial Pascal supply agreements expected with Chromacare and UK stroke detection partner
3. Mid-2026: Active Syphilis clinical trials anticipated to commence
4. Ongoing: Liver test evaluation by multinational pharmaceutical company in US drug trial

The company’s financial position, characterised by $3.51 million cash, no debt, and 49% reduction in underlying EBITDA losses, positions it to execute on these milestones whilst maintaining operational flexibility. Pascal technology validation in US clinical studies, combined with customer diversification and a broadening diagnostic test portfolio, supports the investment thesis centred on revenue growth and margin improvement.

Get Healthcare Breakthroughs Before the Market Reacts

Join 20,000+ investors receiving FREE real-time ASX healthcare alerts with expert analysis delivered within minutes of release. Click the “Free Alerts” button at Big News Blast to catch the next diagnostic technology breakthrough the moment news breaks.