Archer Materials (ASX: AXE) Advances Potassium Biosensor With Blood Collection Study

Archer Materials has completed an early pre-pilot blood collection study supporting development of its potassium Biosensor.

The 20-donor study compared conventional venous collection with several capillary, or finger-prick, approaches. One capillary method produced consistently low haemolysis levels broadly comparable with conventional venous collection.

The findings will shape Archer’s beta prototype and its blood collection and processing workflow. They are also expected to support future regulatory engagement, including a US Food and Drug Administration Pre-Submission.

Managing a Key Source of Error

Haemolysis occurs when red blood cells are damaged during or after collection. That damage can release additional potassium into a sample, potentially producing an artificially elevated reading.

Consequently, a reliable potassium test requires more than a functioning Biosensor. Archer must also measure and manage haemolysis across the sample-to-result process.

The latest study assessed haemolysis using established laboratory methods. While one capillary approach delivered low levels, other methods produced higher haemolysis.

Those comparisons helped Archer identify which collection methods are most suitable for further development. The work also provides engineering inputs before blood reaches the sensor itself.

Archer Chief Executive Officer Dr Simon Ruffell said: “Damage to red blood cells during collection can release potassium into the sample and potentially lead to an artificially high result.”

From Components to an Integrated System

Archer described the work as an early pre-pilot development study. Importantly, it was not a clinical validation study of the potassium Biosensor.

Instead, the study supports Archer’s shift from developing individual components toward an integrated beta blood-testing system. That distinction defines the current stage of the program.

The company is developing the sensor alongside blood-processing components and a haemolysis measurement sensor. Collection and preparation procedures must also be incorporated into the overall testing workflow.

This work follows Archer’s earlier haemolysis sensor development and evaluation, reported in March 2025 and July 2026. The latest study extends that work into sample handling and preparation.

Next Development Steps

Archer will now combine the preferred collection approach with its blood-processing components and Biosensor technology. This will allow broader evaluation of the complete sample-to-result workflow.

The company said that integrated approach is consistent with its development pathway for 2026. Its objective is to reduce potential sources of error affecting potassium measurement.

The data will also inform procedures for future pilot and pivotal studies. These include blood collection methods and controls for sample quality.

Archer expects the findings to contribute to planned regulatory discussions, including a future FDA Pre-Submission. However, the announcement did not provide a date for that engagement.

Ruffell said the results support progression “from individual prototype components towards an integrated beta system”. He added that they would help design the pilot and pivotal studies needed for future development.

Archer operates within the semiconductor industry and develops devices for quantum computing, sensing and medical diagnostics. The potassium Biosensor program applies that semiconductor capability to medical testing.