Atomo Opens New Growth Path With Gen 4 HIV Test Partnership

Atomo Opens Gen 4 HIV Development Program

Atomo Diagnostics Limited (ASX:AT1) is targeting a commercial launch within 24 months for a new fourth-generation HIV rapid test, in a partnership that gives the company another potential product for its own pipeline. The agreement with Innovation Scientific follows the completion of feasibility studies and covers further development, analytical work and clinical studies using Atomo’s Galileo cassette.

The proposed test is designed to detect HIV-1/2 antibodies as well as the HIV-1 p24 antigen. That combination can enable earlier identification of infection than antibody-only third-generation tests, although performance depends on factors including the test design, specimen type and stage of infection. The product would use lateral-flow technology to deliver blood-based results at the point of care.

Atomo Takes Manufacturing and Regulatory Role

Innovation Scientific will complete the development and study program, while Atomo will be the legal manufacturer and seek registration with Australia’s Therapeutic Goods Administration and under Europe’s In Vitro Diagnostic Regulation. The company expects those regulatory steps to take place over the next 18 months, subject to the required development and clinical outcomes.

The partnership broadens a portfolio that already includes Atomo’s Gen 3 HIV product and Active Syphilis program. That expansion follows a period in which HIV self-testing growth helped drive the company’s FY26 revenue higher, according to recent company reporting. Atomo says the combined portfolio is intended to serve healthcare providers, self-test and professional markets, public-health programs and distribution partners seeking HIV and STI testing in decentralised settings.

Definitive Agreements Still Need to Be Signed

The MOU is a development pathway rather than a completed commercial deal. Atomo and Innovation Scientific have agreed to negotiate licence, development and supply agreements within four months, with both parties initially covering their own costs. Intellectual property in the assay strip will remain with Innovation Scientific, while Atomo retains the intellectual property in the Galileo cassette and would receive a global commercialisation licence for the finished test.

By the end of the third quarter of 2027, the parties expect to execute a detailed supply agreement under which Innovation Scientific would combine Atomo’s Galileo sub-assemblies with its test strip and buffer to produce the packaged product. The announcement does not disclose pricing, revenue forecasts or other commercial and financial terms.

Pipeline Adds Another Regulatory and Execution Test

Atomo’s board describes the agreement as strategically significant relative to the company’s current revenue base and expects the Gen 4 HIV product to contribute from FY28 and beyond. Chief executive Cheri Walker said the company expects Gen 4 HIV and Active Syphilis products to launch within the next 24 months, while the company’s earlier syphilis test development remains part of the same broader product expansion effort.

For shareholders, the attraction is clear enough: a new assay could give Atomo another route to monetise its existing cassette technology and deepen its HIV and STI offering. The harder part is still ahead. The MOU must become binding commercial agreements, the test must produce acceptable analytical and clinical evidence, and TGA and IVDR approvals must arrive before the 24-month launch target can become more than a timetable.