Atomo signs MOU with Innovation Scientific to develop a Generation 4 HIV test
Atomo Diagnostics (ASX:AT1) has signed a Memorandum of Understanding (MOU) with Innovation Scientific for a Generation 4 HIV rapid test in its Galileo cassette. The announcement is dated 29 October 2026.
Following the recent completion of feasibility studies, Innovation Scientific will conduct additional development, analytical and clinical studies. Atomo will be the legal manufacturer of the assay, and the Parties agree to negotiate license, development and supply agreements under which Atomo will commercialise the rapid Generation 4 HIV assay on a global basis.
The Board considers the agreement to be strategically significant to Atomo, having regard to its current revenue base and the expected contribution of the Gen 4 HIV product in FY28 and beyond. The headline points are:
- Atomo formally launches a development program for Gen 4 HIV in its Galileo cassette, in partnership with Innovation Scientific.
- Innovation Scientific will complete the development, analytical and clinical studies.
- Atomo will be the manufacturer of record, with plans to seek regulatory approval from the Therapeutic Goods Administration (TGA) and for the In Vitro Diagnostic Regulation (IVDR).
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Why Generation 4 testing matters
Gen 4 versus Gen 3 explained
Fourth-generation HIV tests are designed to detect both HIV-1/2 antibodies and the HIV-1 p24 antigen. An antigen is a protein from the virus itself, rather than the body’s immune response to it.
The addition of p24 antigen detection can enable earlier identification of infections compared with antibody-only third-generation tests, depending on the test’s performance, specimen type and stage of infection.
Gen 4 rapid tests use lateral-flow technology to detect these biomarkers in a blood sample. Results are delivered at the point of care without conventional laboratory equipment.
Fit with the existing portfolio
The Gen 4 HIV test is intended to expand Atomo’s global franchise in HIV testing, strategically complementing its existing Gen 3 HIV and Active Syphilis portfolio. It would broaden the offering across HIV screening, earlier infection detection and sexually transmitted infection (STI) testing.
The expanded portfolio is intended to strengthen Atomo’s position with healthcare providers, self-test markets, professional markets, public-health programs and distribution partners seeking integrated HIV/STI screening solutions in decentralised testing locations.
Demand for Atomo’s existing HIV products is already visible, with a $630,000 HIV self-test order from the NAPWHA program backed by Federal Government funding.
The growing product portfolio provides commercial synergies as Atomo scales its business by introducing revenue from its own new product pipeline beginning in late FY2028.
Atomo’s FY26 revenue growth of 41% to $5.3m, alongside a debt-free balance sheet, shows the current revenue base against which the Gen 4 HIV contribution from FY28 will be measured.
Key agreement terms
The MOU sets out the following framework, with other commercial and financial terms still to be finalised.
| Term | Detail |
|---|---|
| Counterparty | Innovation Scientific Pty Ltd, an Australian-based diagnostic company |
| Term | Covers the period of development, clinical trials and IVDR registration for the Gen 4 HIV product |
| Intellectual Property | IP for the strip component of the assay remains with Innovation Scientific, with Atomo licensed to commercialise globally. The IP for the Galileo cassette remains with Atomo. |
| Financial Terms | Both Parties cover their costs; other commercial and financial terms to be finalised in supply, license and development agreements |
Innovation Scientific was founded in 2014 in Sydney. It is ISO 13485 certified, became Medical Device Single Audit Program (MDSAP) certified in 2025, and is TGA approved.
Cheri Walker, CEO, Atomo Diagnostics
“We are pleased to be immediately fulfilling our promise of adding new products to Atomo’s own product development pipeline on an accelerated timeline through our partnership with Innovation Scientific…”
Walker also said: “We expect the commercial launch of both Gen 4 and Active Syphilis products within the next 24 months, establishing new revenue streams and supporting Atomo’s next phase of growth.”
What happens next for Atomo and the Gen 4 HIV program
The announcement sets out a sequence of milestones:
- License, development and supply agreements: within the next four months, the Parties agree to negotiate these agreements, with Atomo to commercialise the assay on a global basis.
- Regulatory registration: Atomo plans to register the product under IVDR and with the TGA over the next 18 months.
- Detailed supply agreement: by the end of 3Q27, the Parties expect to execute it, with Innovation Scientific incorporating Atomo’s Galileo sub-assemblies with the Innovation Scientific test strip and buffer, delivering a final packaged product.
- Commercial launch: Atomo expects to launch the product commercially within 24 months.
- Revenue: revenue from Atomo’s own new product pipeline is expected to begin in late FY2028.
For investors, the program points to a broader HIV/STI franchise built on the Galileo platform. The commercial and financial terms remain to be finalised in the supply, license and development agreements.
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