Regulatory Milestones Ahead for Atomo’s Novel Liver Injury Diagnostic

Exclusive Licensing Deal Expands Atomo’s Diagnostic Portfolio

Atomo Diagnostics Limited (ASX, AT1) has announced a significant strategic move by securing an exclusive global licensing agreement with the Burnet Diagnostics Initiative for a novel liver function test. This test measures alanine aminotransferase (ALT), a critical enzyme indicating liver inflammation and damage, and will be delivered on Atomo’s established Pascal rapid diagnostic platform.

The license extends until the expiry of the underlying patents, projected to last until December 2044, positioning Atomo to commercialise a rapid, easy-to-use test that can be deployed both at the point-of-care and in home settings. This development aligns with Atomo’s broader strategy of expanding its footprint in rapid diagnostics beyond infectious diseases into chronic and acute conditions.

Targeting Drug-Induced Liver Injury and Beyond

The initial commercial focus for the test is monitoring drug-induced liver injury (DILI), a serious adverse effect where rapid detection of ALT elevations can prompt urgent clinical intervention. Atomo has already fulfilled an order for 20,000 Pascal cassettes to support a multinational pharmaceutical company’s US drug trial, underscoring early commercial traction.

Beyond DILI, the test holds promise for routine screening and monitoring of chronic liver diseases such as viral hepatitis B and C, fatty liver disease, and alcoholic liver disease. These conditions represent a substantial global health burden, and a rapid, point-of-care ALT test could facilitate earlier diagnosis and better patient outcomes.

Financial Terms and Regulatory Milestones

Under the agreement, Atomo will pay Burnet royalties based on net revenues, with reduced rates for sales in low- and middle-income countries to accommodate pricing sensitivities. While specific royalty rates remain confidential, Atomo confirms they are consistent with industry norms.

Atomo has committed to an immediate licensing milestone payment of $150,000, with further milestone payments totaling $650,000 contingent on securing regulatory approvals from key markets including the US Food and Drug Administration (FDA), Europe’s In Vitro Diagnostic Regulation (IVDR), and Australia’s Therapeutic Goods Administration (TGA). The company notes that extensive prior development and clinical validation reduce regulatory risk and may accelerate submission timelines.

Building on a Successful Partnership

This agreement builds on Atomo’s existing collaboration with Burnet, which includes the commercialisation of a novel Active Syphilis test under a federal government grant. Atomo’s Managing Director John Kelly highlighted the strength of this partnership and the broad clinical utility of the liver function test across multiple liver conditions.

Burnet’s Director of Commercialisation, Jen Barnes, emphasised the test’s potential to improve patient outcomes by enabling earlier detection and faster clinical decision-making. Together, the partners aim to bring this innovation to market swiftly and expand its global impact.

As Atomo continues to diversify its product offerings, this liver function test represents a promising addition that leverages its patented Pascal technology platform to address significant unmet needs in liver health diagnostics.