Atomo Diagnostics (ASX:AT1) Limited said on 29 October 2026 that it has signed a memorandum of understanding (MOU) with Innovation Scientific Pty Ltd to develop a Generation 4 HIV rapid test for Atomo's Galileo cassette. The company, a medical device business in the rapid diagnostic test sector, said its board regards the arrangement as strategically significant given its current revenue base and the expected contribution of Gen 4 products from the 2028 financial year.

Who does what

The announcement describes the Galileo cassette as the platform into which the new test would be built, so the project combines Innovation Scientific's strip chemistry with Atomo's existing device design.

Under the MOU, Innovation Scientific will complete development and the analytical and clinical studies, and will supply its test strip and buffer. Atomo will be the legal manufacturer of record and will supply sub-assemblies for its Galileo cassette. The licensing arrangement would allow Atomo to commercialise the assay globally. Each company would retain its own intellectual property, with Innovation Scientific keeping the strip component and Atomo keeping the Galileo cassette. Each party would bear its own costs.

Timetable

The company set out an expected sequence. The parties intend to negotiate licence, development and supply agreements within four months. Atomo plans to register the product under the European In Vitro Diagnostic Regulation (IVDR) and with the Australian Therapeutic Goods Administration over the next 18 months. A detailed supply agreement is expected to be executed by the end of the third quarter of FY27, and commercial launch is expected within 24 months. Atomo said its own new product pipeline is expected to begin generating revenue in late FY2028.

What has not been agreed

The MOU is not a binding licence, development or supply agreement, and those documents have yet to be signed. The announcement did not disclose volumes, prices or dollar values, and said other commercial and financial terms are still to be finalised. Regulatory approvals have not been obtained, and the dates given are the company's expectations, which depend on study outcomes and the outcome of negotiations. The company has therefore not announced any revenue from the arrangement.

Other announcements

The company also lodged an updated investor webinar presentation on 28 October 2026 and two notifications of cessation of securities the same day. The titles of those items do not indicate further commercial developments, and they were not reviewed in detail for this article.

Why the timetable matters

Because registration is planned over 18 months and launch within 24, any revenue from a Gen 4 test would come well after the current period. The company's own statement links the product to its FY2028 outlook, so the key points to watch are whether binding agreements are executed within the four-month negotiation window and whether the stated regulatory filings proceed as planned. The company identified the end of the third quarter of FY27 as the date by which it expects a detailed supply agreement.

Next milestones

The MOU term covers development, clinical trials and IVDR registration.

The immediate milestone is the negotiation of licence, development and supply agreements over the next four months. Subsequent steps are the IVDR and TGA registrations, the supply agreement by the end of the third quarter of FY27 and a launch within two years. Atomo has not said how the development work will be funded beyond each party covering its own costs, and the MOU does not commit either side to a final agreement.