Q1 FY27 highlights: revenue up 140% to $1.63m as pipeline expands
In its Q1 FY27 results presentation dated 29 October 2026, Atomo Diagnostics reported total revenue of $1.63m, up 140% quarter-on-quarter. FebriDx®/OEM revenue reached $939k, a 469% quarter-on-quarter increase.
Management also outlined cash receipts of $2.51m, made up of $2.40m from customer receipts and an $84k CRC-P Active Syphilis grant. The company ended the quarter with $2.67m in cash.
The presentation listed three pipeline milestones:
- The Upfront Diagnostics and Atomo partnership on a next-generation rapid Pre-Hospital LVTwo Brain Disease Test
- A Generation 4 HIV development agreement with Innovation Scientific PTY LTD
- Active Syphilis transferring to manufacturing, with preparation progressing for clinical trials to begin in the new calendar year
Together, the figures point to revenue shifting from a single franchise towards a more diversified base spanning HIV, OEM supply and new pipeline products.
HIV franchise growth
HIV sales rose 38.3% year on year, from $456k in Q1 FY26 to $630k in Q1 FY27. The company attributed the growth to increased international supply to Viatris Healthcare (Pty) Ltd and to ANZ pharmacy channels.
ANZ pharmacy sales rose 39.5% quarter-on-quarter, with Australian wholesalers up 41.3% and New Zealand retail up 30.3%. Existing ANZ health and community accounts also placed further orders.
OEM model and FebriDx®
OEM sales revenue rose from A$165k to A$939k, while devices supplied grew 713% quarter-on-quarter. The presentation described the result as flu-season inventory build driving triple-digit revenue and device-volume growth.
Lumos-reported live US FebriDx® sites increased from 170 in July to 215 in September 2026, a 26.5% rise. Sites under evaluation numbered 405, compared with 350 in July, and the presentation noted that a March 2026 FDA CLIA waiver expanded eligible US testing settings.
The FDA CLIA waiver widened eligible US testing settings to pharmacies, urgent care clinics and physician offices, and because every FebriDx® test needs a Pascal cassette from Atomo, rising site numbers feed directly into OEM revenue.
The closing slide separately cited FebriDx® revenue of $683k, up 314% year on year, with device supply up 501%. These figures are distinct from the $939k total OEM revenue.
When big ASX news breaks, our subscribers know first
Financial results: strong revenue growth, margin and loss movements
Revenue and gross profit increased year on year, while gross margin narrowed and losses widened. Operating expenditure rose 51%, which the presentation set alongside the broader product pipeline build.
| Metric (A$’000) | 1Q FY27 | 1Q FY26 | Change |
|---|---|---|---|
| Revenue | **1,628** | 680 | **+140%** |
| Gross profit | **424** | 256 | **+66%** |
| Gross margin | **26%** | 38% | **-11.6 pts** |
| EBITDA | **(1,337)** | (983) | **+36% loss** |
| PBT | **(1,627)** | (1,368) | **+19% loss** |
Figures are unaudited for Q1 FY27. Cost of sales rose 184% to $1,204k, and other income was $217k.
The quarter builds on FY26 revenue growth of 41% to $5.3 million, when OEM revenue surged 209% and the company closed the year debt-free with $3.71 million in cash.
Balance sheet and cash flow
At September 2026, the balance sheet showed:
- Cash and cash equivalents of $2.67m
- Total assets of $9.63m
- No bank borrowings
- Net assets of $6.15m (6,145k)
Net cash used in operating activities was $929k, and the net decrease in cash was $1.01m. Cash at the beginning of the period was $3.709m.
Gen 4 HIV and brain disease tests open new revenue paths
Atomo outlined three programmes extending its product base beyond current commercial lines.
Gen 4 HIV with Innovation Scientific
Under a memorandum of understanding (MoU), Atomo is to receive a global licence to commercialise a rapid Gen 4 HIV assay in its Galileo cassette. Feasibility testing is complete, and the parties are to negotiate the final Supply Agreement and Licence over the next four months.
Innovation Scientific is to complete final assay development and run analytical and clinical studies with Atomo. Atomo is to manufacture and supply Galileo sub-assemblies, hold the global assay licence, act as legal manufacturer and lead IVDR and TGA registration, launch and commercialisation. The presentation cited an HIV global rapid-test kit market of A$1.16bn.
Upfront LVTwo brain disease test
LVTwo is a rapid blood-based brain-disease test designed for use before hospital arrival, to help emergency teams triage suspected stroke or other brain disease patients sooner. It is to be deployed in Atomo’s hand-held device, and 9,000 Atomo sub-assemblies have been supplied for validation and verification activities to date.
The presentation cited 11.9 million new strokes worldwide annually. Regional figures, including 54,800 in Australia and New Zealand, use different years and methodologies and do not represent addressable test demand.
Active Syphilis
The Active Syphilis test is a 15-minute rapid lateral flow test designed to detect infectious syphilis and distinguish active cases from previously treated cases. Early clinical testing showed 100% sensitivity against active syphilis samples by clinical history, 99% specificity against never-infected patients and 93% specificity against previously treated cases.
Test-strip manufacturing moved from Burnet Institute in Melbourne to Cape Town for clinical-trial production builds.
Proprietary pipeline stages
| Product / application | Stage |
|---|---|
| HIV Gen 3 (screening / self-test) | Commercial |
| Active Syphilis (active vs treated infection) | Validation |
| HIV Gen 4 (antibody + p24 antigen) | Development |
| Liver / ALT (liver health screening) | Development |
| HCV (hepatitis C virus) | Feasibility |
| HBV (hepatitis B virus) | Feasibility |
Gen 3 versus Gen 4 HIV testing explained
Gen 3 is an established antibody-based HIV self-test used by individuals through pharmacy, community, public health and rapid screening channels. Its markets include Europe, the UK, ANZ, LMIC and others.
Gen 4 is a proposed rapid antigen/antibody test operated by clinicians and trained professionals. Its channels are sexual health, primary care and clinical point-of-care, with focus markets of Europe/UK, ANZ, APAC and the USA.
The presentation gave distinct 2025 category estimates: A$4.62bn for all HIV diagnostics, A$1.16bn for HIV rapid-test kits and A$341m for HIV self-testing.
Atomo stated Gen 4 expands professional-use buyers, clinical uses and procurement pathways beyond self-testing, though overlap remains possible in assisted testing. It also noted potential as the market evolves to support ongoing Pre-Exposure Prophylaxis (PrEP), a prescription medicine taken by HIV-negative people to lower the risk of getting HIV.
What happens next for Atomo
The presentation set out the following forward milestones:
- Gen 4 HIV agreements: the parties are to negotiate the final Supply Agreement and Licence over the next four months.
- Gen 4 HIV registration and launch: a planned 18-month IVDR and TGA registration window, with commercial launch targeted at 24 months. Own-pipeline revenue is targeted from late FY2028.
- Active Syphilis clinical trials: expected to commence early next year.
- Active Syphilis regulation and launch: engagement is planned with TGA, FDA and BSI, with commercial launch targeted within 18-24 months.
- Investor webinar: Atomo will hold its Q1 FY27 Quarterly Investor Webinar on Tuesday 03 November 2026 at 2pm (AEDT), with pre-registration required.
Get Healthcare News Before the Market Moves
Join 20,000+ investors receiving FREE breaking ASX news from Big News Blast within minutes of release, complete with in-depth analysis. Click the “Free Alerts” button to get the next healthcare and diagnostics story in your inbox the moment it breaks, and stay ahead of the market.