Archer Materials (ASX: AXE) has advanced development of its Biosensor medical device after building an alpha prototype using the company’s Biochip technology that achieved clinical-grade potassium sensing accuracy.
The alpha system integrated the company’s Biochip, microfluidics, and readout electronics into a fully integrated prototype device.
Archer is now developing a beta prototype Biosensor suitable for preclinical validation and future patient clinical trials.
The beta prototype is being designed as a robust user-ready and manufacturable system to support future clinical workflows and commercial deployment pathways.
The company plans to develop multiple beta prototype versions, with refinements to be informed by external testing, studies, and validation work.
Testing Timeline Imminent
Archer has completed the first beta prototype cartridge design, with initial part revisions released for manufacturing.
The first beta prototype system is expected to become available for testing in coming months, with further optimisation and validation activities planned throughout the second half of 2026 and a fully optimised beta prototype targeted for use in trials in 2027.
Development activities are progressing across cartridge engineering, readout electronics, chip integration ,and manufacturing preparation.
The handheld readout electronics and control system have also advanced toward manufacturing release beyond the alpha prototype version.
Further productisation activities have commenced with IMEC, including the supply of advanced Biochips and Archer’s proprietary functionalisation processes for future beta prototype generations.
Scale-Up and Manufacturing Pathways
Archer is engaging with contract development and manufacturing organisations to support future scale-up, manufacturing pathways, and clinical deployment activities.
The company is also advancing its intellectual property roadmap, including preparation of provisional patent filings linked to the Biochip platform and system integration technologies.
Chief executive officer Dr Simon Ruffell said the program marked a more advanced stage of Biosensor development.
“The beta prototype program is focused on developing a more refined, user-ready, and manufacturable diagnostic system suitable for external validation, future clinical studies, and commercial deployment pathways,” he said.
“This includes advancement of the cartridge design, handheld electronics, Biochip integration, and sensing platform into a more refined and manufacturable diagnostic system.”
Broader Application Potential
The Biochip platform is also being assessed for additional diagnostic uses beyond potassium sensing, with early feasibility testing underway for lithium monitoring in blood, targeting potential applications in managing bipolar and other mood disorders treated with lithium-based medication.
Archer anticipates these activities will support engagement with medtech partners, clinical collaborators and manufacturing groups as it advances toward potential commercialisation opportunities.
“We are encouraged by the early feasibility testing underway for additional applications, including lithium monitoring in blood which may broaden the long-term commercial potential of the Biochip platform,” Dr Ruffell said.
“We believe the ongoing engineering and productisation progress continues to significantly de-risk the Biosensor and Biochip technology and positions Archer well for the next stage of external validation and commercial discussions.”
