Exclusive Licence for a Novel Liver Function Test on Pascal
Released
Released
Announcement PDF
Atomo Diagnostics Limited
ACN 142 925 684
Level 1, 3-5 George St Leichhardt NSW 2040
ASX Announcement 20 January 2026
Atomo Secures Exclusive Licence for a Novel Liver Function Test on Pascal
SYDNEY, 20 January, Australia, 2026 - Atomo Diagnostics Limited (ASX:AT1) (Atomo) is
pleased to announce signing an exclusive global licensing agreement with the Burnet
Diagnostics Initiative, part of The Macfarlane Burnet Institute for Medical Research and
Public Health. The agreement remains in effect until the date of expiry of the last of all of
the patents forming part of the Patent Rights, projected to be December 2044.
The license for Burnet’s novel liver function test assay supports commercialisation of a
rapid test for the immediate detection of liver injury through measurement of alanine
aminotransferase (ALT), a key indicator of liver inflammation and damage. Delivered on
Atomo’s proven Pascal cassette at the point-of-care and in the home, the test enables
early identification of liver inflammation of any cause, giving the test commercial utility
across a broad range of clinical applications.
The initial focus is monitoring for drug-induced liver injury (DILI) where rapid elevations
in ALT require an urgent clinical response. Atomo previously disclosed fulfilling an order
from Burnet for 20,000 Pascal cassettes to support supply of finished tests to a
multinational pharmaceutical company to enable real-time monitoring of DILI in a US
drug trial. (AT1 Quarterly Activity Report Q3 FY24, 29th
April 2024).
The global market potential for an easy-to-use rapid test that can be utilised by patients
commencing drug treatments with known liver injury risk is significant. With product
development substantively complete, diagnostic performance established and a large
multinational pharmaceutical company evaluating the test, Atomo believes the securing
of an exclusive worldwide license for the test is material.
Atomo Diagnostics Limited
ACN 142 925 684
Level 1, 3-5 George St Leichhardt NSW 2040
Other priority clinical applications identified by Atomo and Burnet include routine
screening and monitoring of common chronic liver conditions such as viral hepatitis (B
and C), fatty liver disease and alcoholic liver disease.
The agreement between Atomo and Burnet builds on the successful partnership
between the parties for a development program to commercialise a novel test to detect
Active Syphilis, under a federal government CRC-P grant. (AT1: ASX Announcement 24th
March 2025: Atomo Secures Exclusive Licence for a Novel Syphilis Test on Pascal).
Under this agreement for a Pascal Liver Function test, Atomo commits to pay Burnet
royalty payments as a percentage of net revenues generated by the Product, with a lower
royalty rate applied to sales in low-middle income countries (LMIC’s) where pricing is
typically lower. Whilst the agreed royalty arrangements are commercial in confidence,
Atomo confirms they are consistent with royalties that are standard for an agreement of
this nature in the diagnostics industry.
There are no material conditions that need to be fulfilled before the agreement comes
into full effect, however under the agreement Atomo commits to an immediate licencing
milestone payment to Burnet of $150,000.
Royalty payments to Burnet under the agreement will not be applicable until after the
Product has secured regulatory approval. Licencing milestone payments are also due
upon the Product securing regulatory approvals in the US (FDA), Europe (IVDR) and
Australia (TGA), with the regulatory milestone payments totalling $650,000 in the event
the Product is approved in all key markets. The extensive development and clinical work
undertaken to date on Pascal reduces product development risk and anticipated
timelines to regulatory submissions.
Atomo Diagnostics Limited
ACN 142 925 684
Level 1, 3-5 George St Leichhardt NSW 2040
Atomo Managing Director John Kelly said, “We have developed an excellent working
relationship with Burnet through our existing partnership on Active Syphilis and are
delighted to expand this strategic engagement to now include an exciting novel Liver test
with broad clinical utility across a range of common acute and chronic liver conditions”.
Burnet Institute Director of Commercialisation Jen Barnes said, “The Burnet Diagnostics
Initiative is focused on developing market-ready products that address real-world
clinical needs and improve outcomes for patients. An easy-to-use point-of-care ALT test
has the potential to benefit multiple patient populations across a range of conditions by
enabling earlier detection, faster clinical decision-making, and more timely access to
appropriate care. We are delighted to partner with Atomo to bring this important
innovation to market as quickly as possible and expand its impact globally.”
For more information, please contact:
John Kelly
Atomo Diagnostics
john.kelly@atomodiagnostics.com
Phone: +61 401 922 279
This announcement was authorised by the Managing Director & Board.
About Atomo
Atomo is an Australian headquartered medical device company supplying unique, integrated rapid
diagnostic test (RDT) devices to the global diagnostic market.
Atomo’s unique patented devices simplify testing procedures, enhance usability and improve reliability
across rapid point-of-care (POC) and at-home testing applications. The Company has successfully
commercialised a number of products across international markets and has supply agreements in place
for testing applications targeting infectious diseases including HIV, COVID-19, viral vs bacterial
differentiation, as well as the early detection of pregnancy.
See more at www.atomodiagnostics.com
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