Atomo Signs Agreement with Innovation Scientific
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Atomo Diagnostics Limited
ACN 142 925 684
Level 1, 3-5 George St Leichhardt NSW 2040
ASX Announcement 29th
October 2026
Atomo Signs Agreement with Innovation Scientific to Develop a Generation 4
HIV Assay
• In partnership with Innovation Scientific, Atomo formally launches a development
program for Gen 4 HIV in its Galileo cassette
• Innovation Scientific will complete the development, analytical and clinical studies
• Atomo will be the manufacturer of record with plans to seek regulatory approval
from TGA and for IVDR
SYDNEY, Australia, 29th October 2026 - Atomo Diagnostics Limited (ASX:AT1 or Atomo) is
pleased to announce a Memorandum of Understanding (MOU) with Innovation Scientific
related to a Generation 4 HIV rapid test in Atomo’s Galileo cassette. Following the recent
completion of feasibility studies, Innovation Scientific will conduct additional development,
analytical and clinical studies. Within the next four months, the Parties agree to negotiate
license, development and supply agreements where Atomo will commercialise the rapid
Generation 4 HIV assay on a global basis.
Atomo will be the legal manufacturer of the assay and plans to register the product under
IVDR and with the TGA over the next 18 months. By the end of 3Q27, the Parties expect to
execute a detailed supply agreement whereby Innovation Scientific will incorporate Atomo’s
Galileo sub-assemblies with the Innovation Scientific test strip and buffer, delivering a final
packaged product. Atomo expects to launch the product commercially within 24 months.
Fourth-generation HIV tests are designed to detect both HIV-1/2 antibodies and the HIV-1
p24 antigen. 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, delivering results at the point of
care without conventional laboratory equipment.
Atomo Diagnostics Limited
ACN 142 925 684
Level 1, 3-5 George St Leichhardt NSW 2040
The Gen 4 HIV test will expand Atomo’s global franchise in HIV testing, strategically
complementing Atomo's existing Gen 3 HIV and Active Syphilis portfolio, broadening its
offering across HIV screening, earlier infection detection and sexually transmitted infection
(STI) testing. Together, 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. 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.
Key Agreement Terms
• Counterparty: Innovation Scientific Pty Ltd, an Australian-based diagnostic company.
• Term: The term covers the period of time 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.
• Materiality: The Board considers this 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.
Atomo’s CEO Cheri Walker said, “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. The partnership allows Atomo to
rapidly complete the development and studies necessary to pursue the appropriate
regulatory filings required for commercial launch of the product. 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.
Atomo is committed to growing its franchise of commercialised rapid point of care devices
targeted to the professional and self-test markets, where its technologies bring better
performance and ease of use to blood-based rapid testing. Alongside our Active Syphilis
program, the Gen 4 HIV initiative represents an opportunity to build a broader portfolio of
rapid diagnostic solutions for professional healthcare and self-testing markets. Our focus is
on translating our technology and product development capabilities into commercially viable
products that can support more accessible testing in decentralised settings and contribute to
Atomo’s future growth.”
Atomo Diagnostics Limited
ACN 142 925 684
Level 1, 3-5 George St Leichhardt NSW 2040
For more information, please contact:
Cheri Walker, PhD
Atomo Diagnostics
cheri.walker@atomodiagnostics.com
Phone: +61 2 9099 4750
This announcement was authorised by the Managing Director & CEO on behalf of the Board.
About Atomo
Atomo is an Australian headquartered medical device company supplying unique, integrated rapid
diagnostic test (RDT) devices to the global diagnostic market.
Atomo’s unique patented devices simplify testing procedures, enhance usability and improve reliability
across rapid point-of-care (POC) and at-home testing applications. The Company has successfully
commercialised a number of products across international markets and has license, development and
supply agreements in place for testing applications targeting infectious diseases including HIV, active
syphilis, ALT liver test, early detection of pregnancy, ferritin, and stroke.
See more at www.atomodiagnostics.com
About Innovation Scientific
Founded in 2014 in Sydney, Innovation Scientific is an ISO 13485 certified, and in 2025 is now a Medical
Device Single Audit Program (MDSAP) certified, TGA approved, Australian manufacturing and
marketing company of in-vitro diagnostic (IVD) reagents, kits and instruments for national and
international markets. Their testing technology helps revolutionise access to healthcare solutions and
deliver improved healthcare outcomes. They are focused on rapid testing solutions that put the user in
the centre of the testing experience and specialise in infectious disease testing, including 4:1
COVID/RSV/FluA/FluB and drugs of abuse assays.
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