Archer Materials Advances Biochip Toward Beta Prototype and Clinical Validation

Archer advances Biochip potassium sensor to beta prototype on silicon, kicking off pre-clinical trials as licensing talks begin.

IC
Imelda Cotton
·2 min read
Archer Materials Advances Biochip Toward Beta Prototype and Clinical Validation

Key points

  • Beta prototype progressing on silicon; IMEC Stage 1 complete.

  • Alpha prototype hit clinical-grade accuracy; CLIA-compliant.

  • Silicon favored; graphene to follow.

Archer Materials (ASX: AXE) has advanced its Biochip potassium-sensor program toward the development of a beta prototype following completion of a Stage 1 project with Interuniversity Microelectronics Centre (IMEC) in Belgium.

The prototype will integrate the Biochip along with Archer’s proprietary functionalisation, measurement methodology, and readout electronics within a next-generation cartridge format suitable for external use.

It will be subject to pre-clinical trials and accelerated in-house development of potassium testing and feasibility studies for Archer’s pipeline of Biochip applications.

Archer expects to continue developing the hardware towards a final medical diagnostic product while optimising use-case items such as blood sample workflow and user experience, considered key to clinical trial preparation and data collection for regulatory approval.

Preferred Prototype Material

Silicon has been selected as the preferred material for the beta prototype build due to its faster development timelines and established manufacturing pathways.

However, Archer confirmed that graphene remains its next-generation chip platform for future performance optimisation and product expansion.

For Archer, the core value resides in the ability of its proprietary functionalised layer chemistry and sensing architecture to be deployed across silicon and graphene substrates on various semiconductor sensing chip architectures.

This flexibility is expected to significantly de-risk the Biochip program’s manufacturing and commercialisation.

Clinical-Grade Accuracy

The news follows the unveiling of an alpha prototype of a potassium sensor in January that met clinical-grade accuracy standards and aligned with US CLIA (clinical laboratory improvement amendments) requirements.

The alpha version successfully integrated the test chip, cartridge, and readout electronics to test less than 10 microlitres of blood.

It represented Archer’s first major step in translating Biochip technology from individual laboratory devices into a product suitable for future clinical workflows and point-of-care potassium-in-blood monitoring for patients with chronic kidney disease and heart failure, where rapid detection of elevated blood potassium levels is essential.

The beta prototype will form the basis of licencing negotiations with medical technology companies and engagement with contract medical device manufacturers.

Program Gaining Momentum

Archer chief executive officer Dr Simon Ruffell said the Biochip program continues to gain momentum.

“The completion of the alpha prototype Stage 1 project with IMEC was an important milestone as we continue to progress our Biochip toward commercialisation,” he said.

“It demonstrated that our potassium sensor can be built on a silicon platform without compromising performance while providing advantages in stability and manufacturability.”

“This gives us greater confidence in our ability to scale production, meet target product requirements, and build a pipeline of other applications.”

The company remains focused on translating the outcomes into a beta prototype and advancing to the next phase of product development to support clinical trials and “ultimately bring a practical, easy-to-use diagnostic product to market”.

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