Posted: 27 August 2024
Lumos Diagnostics (ASX:LDX) has extended its existing deal with the Burnet Diagnostics Initiative to progress a new point-of-care test for use in monitoring liver health in an upcoming clinical trial.
As part of the deal, Lumos will produce Alanine Transaminase (ALT) lateral flow tests, customised Lumos readers and a mobile phone application for use in an upcoming US-based clinical trial.
Lumos, a global leader in rapid point-of-care (POC) diagnostic technologies, said the project marks the continuation of the feasibility studies conducted in 2023 to generate a prototype ALT test for evaluation with clinical specimens.
The Company said it will specifically support production of the BDI POC ALT testing system for use by healthcare professionals in a clinical trial with high-risk patients undergoing routine liver function monitoring.
High levels of ALT in the blood can indicate liver injury, possibly from a drug reaction. A POC ALT test can provide rapid on-site results allowing faster detection of acute liver toxicity caused by adverse drug reactions, enabling clinicians to act swiftly to address any liver concerns.
Clinical Trial of BDI ALT test
LDX says results from the BDI ALT test clinical trial will be used to collect real-world data to guide future product development efforts, including a home-based, self-test format.
As part of this engagement with BDI, LDX will perform development, regulatory and manufacturing services over the next 9-12 months, generating fees between US$700,000 ($1m) and US$1m ($1.47m).
Should the project prove successful, LDX anticipates further supporting BDI in its next phase of trials and regulatory submissions.
The BDI is a commitment by the Burnet Institute in Melbourne to develop the systems, resources and processes to support diagnostic product development, and to enhance translation of its POC diagnostics research into practical health solutions.
Specialist in POC testing
LDX specialises in rapid, comprehensive POC diagnostic technology, supporting healthcare professionals in accurately diagnosing and managing medical conditions.
The Company provides customised assay development, manufacturing services for POC tests, and proprietary digital reader platforms.
Lumos also develops, manufactures, and markets its own branded POC tests focused on infectious and inflammatory diseases.
The Company recently announced its FebriDx POC test to differentiate a viral from bacterial acute respiratory infection will be available in Australia and New Zealand.
Working together to ‘improve patient outcomes’
LDX CEO Doug Ward said extending its partnership with BDI solidifies a strong relationship between the two companies built on successful collaborations.
“This contract win emphasises Lumos’ capabilities and provides another opportunity to utilise our reader and the application of intellectual property to address critical unmet clinical needs in the diagnostics arena,” he said.
“We are committed to enhancing the landscape of point-of-care testing and are excited about the possibilities this project holds.”
BDI Director Jennifer Barnes said its ongoing collaboration with Lumos is a testament to the synergy between the organisations.
“Together, we are working towards innovative solutions that will ultimately improve patient outcomes,” she said.
“We appreciate Lumos’ dedication and expertise in developing and manufacturing accessible, rapid diagnostic technologies.
“Having a trusted manufacturing partner is key to the BDI rapidly translating our diagnostic innovations.”
