Lumos Diagnostics (ASX:LDX, OTC:LDXHF) has extended an agreement with the Burnet Diagnostics Initiative (BDI) to manufacture a lateral flow test and develop and manufacture customised Lumos readers to monitor liver function in an upcoming US clinical trial.
Specifically, the extension of Lumos’ agreement with BDI will see it produce Alanine Transaminase (ALT) lateral flow tests, customised Lumos readers and a mobile phone application.
"Solidifies strong relationship"
“We are proud to announce this extension of our partnership with BDI, solidifying our strong relationship built on previous successful collaborations,” Lumos CEO Doug Ward said.
“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.
"We are committed to enhancing the landscape of point-of-care testing and are excited about the possibilities this project holds.”
Shared expertise
The partnership with BDI continues to strengthen since the company first secured the feasibility project in July 2023. The shared expertise could have a significant impact on point-of-care diagnostic test technology in the near future.
The Burnet Institute is dedicated to establishing the necessary systems, resources and processes to advance diagnostic product development and effectively translate its point-of-care diagnostics research into practical health solutions.
Continuation of feasibility studies
This project marks the continuation of the feasibility studies conducted in 2023 to generate a prototype ALT test for evaluation with clinical specimens.
The new phase of collaboration between BDI and Lumos is scheduled to begin in August 2024 and focuses on supporting the production of the BDI point-of-care ALT testing system, designed for healthcare professionals monitoring high-risk patients’ liver function.
Elevated ALT levels in the blood can signal liver injury, potentially due to a drug reaction.
The point-of-care ALT test aims to provide rapid, on-site results, allowing for quicker detection of acute liver toxicity from adverse drug reactions. This enables clinicians to take timely action regarding liver health concerns.
Data from the BDI ALT test clinical trial will be gathered to inform future product development, including a potential home-based, self-test version.
As part of this collaboration, Lumos will provide development, regulatory and manufacturing services over the next 9-12 months, with expected revenues ranging between US$700,000 and US$1 million.
If the project is successful, Lumos may continue to support BDI in subsequent phases, including further trials and regulatory submissions.
Burnet Diagnostics Initiative CEO Jennifer Barnes said, “Our ongoing collaboration with Lumos is a testament to the synergy between our organisations. Together, we are working towards innovative solutions that will ultimately improve patient outcomes.
"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.”
Point-of-care diagnostic test technology
Lumos specialises in advanced point-of-care diagnostic test technology, enabling healthcare professionals to diagnose and manage medical conditions with greater accuracy.
The company provides customised assay development and manufacturing services for point-of-care tests, along with proprietary digital reader platforms.
In addition to these services, Lumos also develops, manufactures and commercialises its own range of innovative Lumos-branded point-of-care tests, focusing on infectious and inflammatory diseases.