Atomo Secures Exclusive Rights to Burnet’s Novel Liver Function Test, Expands Pascal Platform Utility

Atomo Diagnostics (ASX:AT1) has strengthened its diagnostic product suite by securing a global exclusive licence for a novel liver function test developed by the Burnet Diagnostics Initiative, part of The Macfarlane Burnet Institute for Medical Research and Public Health. The licence grants Atomo commercial rights until the expiry of the final patent covered under the agreement, projected to run until December 2044.

The test, which measures alanine aminotransferase (ALT), is designed for the rapid detection of liver injury and inflammation. Delivered via Atomo’s integrated Pascal cassette platform, the assay enables immediate results at the point of care or at home, supporting early diagnosis of liver inflammation regardless of cause.

The primary focus is drug-induced liver injury (DILI), where sudden elevations in ALT can signal a need for urgent clinical response. Atomo previously fulfilled an order of 20,000 Pascal cassettes from Burnet to support a multinational pharmaceutical company conducting real-time DILI monitoring in a US drug trial.

The liver function test is positioned to address significant clinical and commercial needs. John Kelly, Atomo’s Managing Director, described the test as having “broad clinical utility across a range of common acute and chronic liver conditions”, adding that the agreement builds on the company’s successful collaboration with Burnet on a syphilis test launched under a CRC-P grant in 2025.

The agreement includes milestone payments and royalties. An immediate licence fee of $150,000 is payable to Burnet, with additional milestone payments totalling $650,000 triggered by regulatory approvals in the US (FDA), Europe (IVDR), and Australia (TGA). Royalties will be based on net revenues, with reduced rates applied in low and middle income countries to reflect market conditions. The financial terms were described as being consistent with industry norms for diagnostic licensing.

Other clinical applications in development include monitoring for viral hepatitis B and C, fatty liver disease and alcohol-related liver damage. These conditions affect millions globally, making the test’s commercial potential significant. Burnet’s Director of Commercialisation Jen Barnes noted the test could benefit a wide patient population by “enabling earlier detection, faster clinical decision-making, and more timely access to appropriate care”.

According to Atomo, product development is substantially complete and diagnostic performance has already been established. A large multinational pharmaceutical company is currently evaluating the test, which supports Atomo’s view that securing the exclusive licence represents a material commercial opportunity.

With this latest addition, Atomo continues to broaden the reach of its Pascal platform, which already supports rapid tests for HIV, COVID-19, and pregnancy detection. As the company positions itself at the intersection of usability, speed and clinical relevance, this novel liver assay could prove a timely and strategic fit.