Archer Materials Limited (ASX: AXE) Announces Clinical-Grade Potassium Sensing with Silicon Biochip Technology

Archer Materials Limited (ASX: AXE) has reported a significant development in medical diagnostics, announcing a breakthrough with its Archer Materials Silicon Biochip Technology. This technology has successfully demonstrated clinical-grade potassium sensing accuracy, aligning with both existing graphene technology and rigorous medical standards. The quantum technology company achieved ±0.3 mM potassium sensing accuracy in collaboration with world-renowned research centre IMEC. This marks a crucial step toward commercial viability in the medical diagnostics sector, altering the company’s manufacturing options whilst maintaining clinical excellence across both silicon and graphene platforms. This ASX announcement provides an important investor update regarding the company’s technological progress.

The successful transition from graphene to silicon platforms represents an important shift that addresses key manufacturing challenges, whilst upholding technical excellence. Furthermore, the silicon-based devices delivered faster readout times compared to current graphene field effect transistor (gFET) systems, processing results in approximately 30 minutes. This improvement demonstrates the platform’s potential for high-performance, scalable, and clinically compliant biosensor applications within the expanding point-of-care diagnostics market.

Does Archer Materials’ Biochip Technology Meet Clinical Standards for Potassium Measurement?

The achievement of ±0.3 mM accuracy positions the company’s Silicon Biochip Technology as meeting the Clinical Laboratory Improvement Amendments (CLIA) standard for potassium measurement. This clinical standard is critical for medical diagnostics, particularly for patients with chronic kidney disease who require frequent and accurate potassium monitoring.

IMEC fabricated three distinct types of biochip-based sensor devices using established wafer-scale silicon processing technology. The devices were subsequently modified and functionalised using Archer’s proprietary methods to assess potassium-sensing performance within the clinical range of 2-8 mM. In addition to equivalent accuracy to gFET Biochip devices and CLIA testing requirements, the silicon devices demonstrated shorter conditioning and stabilisation times.

Key Performance Metrics:

The silicon platform offers several advantages over the graphene approach, including de-risked supply chains, reduced unit costs, and accelerated manufacturing pathways. However, both platforms maintain equivalent clinical performance, demonstrating the robustness of Archer’s intellectual property and engineering capabilities. This dual-platform flexibility enhances the company’s position within the competitive medical diagnostics landscape.

Furthermore, initial data from three batches of the first type of silicon Biochip devices demonstrated consistent performance within clinical requirements. The functionalisation and measurement protocols developed by Archer this year proved effective across both graphene and silicon architectures, validating the company’s engineering approach.

What Commercial Advantages Does Archer Materials’ Biochip Technology Provide?

The successful demonstration of the Archer Materials Silicon Biochip Technology significantly broadens Archer Materials’ manufacturing options and enhances the pathway to commercialisation. Silicon fabrication leverages IMEC’s established wafer-scale processing capabilities, enabling mass production that was previously challenging with specialised graphene manufacturing.

Commercial Advantages of Silicon Platform:

• Supply Chain De-risking: Established silicon manufacturing ecosystem reduces dependency on specialised graphene suppliers
• Cost Reduction: Lower unit costs through scalable production methods enable competitive pricing strategies
• Manufacturing Scalability: Proven fabrication processes for high-volume production accelerate market readiness
• Accelerated Timeline: Faster pathway to market readiness through established semiconductor processing infrastructure
• Platform Flexibility: Dual-platform capability provides optionality in addressing different market segments

Dr Simon Ruffell, CEO of Archer Materials, emphasised the milestone’s significance: “Demonstrating that our technology can be built using silicon, rather than graphene, significantly broadens our manufacturing options and enhances our path to commercialisation. By leveraging IMEC’s world-class silicon fabrication capabilities alongside Archer’s proprietary sensor functionalisation methods, we are now positioned to develop a scalable, cost-effective, and clinically relevant biosensor platform.”

The company’s ability to achieve clinical-grade performance across both graphene and silicon architectures demonstrates robust platform flexibility, which reduces technology risk for investors. This dual-platform approach provides optionality in manufacturing and market positioning methods, enabling Archer to select the most appropriate technology for specific applications and customer requirements. Furthermore, the engineering and intellectual property development around the functionalisation of graphene-based devices has been successfully leveraged and transferred to a silicon platform. This successful technology transfer validates Archer’s core competencies and strengthens the company’s intellectual property portfolio across multiple semiconductor platforms.

When Is Commercial Production Expected for Archer Materials’ Biochip?

Based on the current development trajectory and key collaborations, Archer Materials appears positioned for commercial readiness by 2026-2027. The company has outlined an ambitious development schedule that builds upon the successful silicon platform validation achieved through the IMEC collaboration.

Development Timeline:

Remaining 2025 Activities:

• Complete testing of two additional silicon biochip device types to validate performance consistency
• Refine device processing and measurement techniques to enhance measurement precision and speed
• Validate enhanced precision and speed capabilities across multiple device configurations
• Define comprehensive productisation pathway based on silicon platform validation results

2026 Major Initiative:

• Launch large-scope productisation project with IMEC focused on silicon-based potassium sensing
• Focus on chronic kidney disease applications targeting point-of-care diagnostics
• Develop integrated sensor system for at-home monitoring applications
• Begin regulatory approvals pathway planning to accelerate clinical validation

Clinical Pathway (2026-2027):

• Finalise working prototype development incorporating silicon platform advantages
• Progress toward clinical trials for medical device validation
• Initiate medical device validation processes to meet regulatory requirements
• Establish commercial manufacturing partnerships for scalable production

The partnership with IMEC provides critical infrastructure for advancing from proof-of-concept to commercial production, particularly given IMEC’s established expertise in nanoelectronics and digital technologies across health sector applications. IMEC’s world-class silicon fabrication capabilities complement Archer’s proprietary sensor functionalisation methods, establishing a robust pathway to commercial deployment. The progress achieved with IMEC, together with ongoing development efforts across Archer’s collaborations, demonstrates that the company is on track to finalise a working prototype and progress toward clinical trials during 2026 and into 2027. These collaborative outcomes reinforce Archer’s momentum in advancing its Biochip technology toward commercial readiness and clinical validation.

What Market Does the Archer Materials Silicon Biochip Technology Target?

The Archer Materials Silicon Biochip Technology targets the growing chronic kidney disease market, which affects over 850 million patients globally requiring regular potassium monitoring. The shift toward point-of-care and at-home diagnostics creates substantial market demand for Archer’s technology platform, particularly as healthcare systems increasingly prioritise patient convenience and cost-effective testing solutions.

Target Market Segments:

Clinical Applications:

• Hyperkalemia monitoring: Critical for patients at risk of dangerous heart rhythm abnormalities requiring frequent potassium level assessment
• Chronic kidney disease management: Regular testing for disease progression monitoring to optimise treatment protocols
• Point-of-care emergency testing: Rapid diagnosis in clinical settings to enable timely medical interventions
• At-home patient monitoring: Enabling patients with chronic conditions to manage their health proactively

Furthermore, the 2026 productisation project with IMEC specifically targets chronic kidney disease applications, focusing on both point-of-care and at-home diagnostic solutions. This primary focus addresses a clearly defined clinical need whilst positioning the company’s biochip technology within a large and growing market segment with demonstrated demand for improved diagnostic capabilities.

How Does Platform Flexibility Affect Archer Materials’ Commercial Position?

The successful validation of the Archer Materials Silicon Biochip Technology across both silicon and graphene platforms demonstrates exceptional engineering flexibility and enhances the company’s competitive position within medical diagnostics. This dual-platform capability is anticipated to provide further resilience in manufacturing and market engagement.

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