Atomo Diagnostics (ASX:AT1) delivered its Chairman's Address at the company's 2026 Annual General Meeting on 5 November 2026, disclosing more than 40% year-on-year growth across its HIV franchise and OEM partnerships combined, with the OEM franchise alone recording more than 200% year-on-year growth during the period.

Key Points

  • Atomo's HIV franchise grew 21% in FY26, with the company's HIV self-test remaining the first to receive Australian TGA approval
  • The OEM franchise posted more than 200% year-on-year growth, with Atomo serving as exclusive licensor, manufacturer and supplier of the Pascal cassette to Lumos (ASX:LDX) for its FebriDx® product
  • Dr Cheri Walker transitioned into the Chief Executive role, with founding CEO John Kelly departing after his tenure
  • The company advanced its Active Syphilis product and added ALT liver and Gen 4 HIV to its proprietary product pipeline during the year
  • A capital raising was completed during the year to support working capital and organisational restructuring

HIV Franchise Performance and TGA-Approved Self-Test

According to the Chairman's Address, Atomo's HIV franchise delivered solid growth of 21% in FY26, with the company continuing to drive sales through international markets, pharmacies, and public health applications across Australia and New Zealand. The filing states that Atomo's technology is proven, being the first HIV/AIDS self-test approved by the Australian Therapeutic Goods Administration. The address noted that the HIV franchise and OEM partnerships together posted significant year-on-year growth of more than 40% as the company executes its strategy of delivering user-centred rapid testing solutions.

OEM Partnerships and Pascal Cassette Technology

The Chairman's Address disclosed that the OEM franchise posted more than 200% year-on-year growth. Atomo is described in the filing as the exclusive licensor, manufacturer and supplier of the Pascal cassette to Lumos (ASX:LDX) for its FebriDx® product. The filing states that FebriDx® has previously secured 510k clearance from the US FDA and received a CLIA waiver from the US FDA. The CLIA waiver trial showed that the Pascal cassette enabled greater than 99% concordance between trained and untrained operators using FebriDx®. Development projects with two OEM providers were also completed during the year for Ferritin and Brain Disease/Stroke indications.

Leadership Transition and Strategic Priorities

The filing disclosed that Atomo transitioned its Chief Executive role to Dr Cheri Walker, with a focus on commercial sales, partnerships and new product pipeline development. Founding CEO John Kelly was acknowledged for his long service to the company. The Chairman's Address outlined strategic priorities including expanding the proprietary test pipeline — referencing active syphilis, ALT liver and HIV Gen 4 products — leveraging the platform for new OEM partnerships, and maintaining operational excellence to build towards profitability. The company also commissioned a second blister machine in Sydney and began development of higher cavitation moulding to improve gross margins, according to the filing.