JUNO-Checked Cassette Development

Purpose and goal:

The aim of the project was to test the feasibility of the cassette to eliminate refrigeration and freezing requirements for storage & shipping to accelerate further clinical evaluation of JUNO-Checked Cassettes. Fulfilment:

The project led to the achievement of the acceptance criteria for Cassette Feasibility, and as a result, the consultants proposed a final assay architecture for optimisation. After this project, the planning will be initiated to evaluate the cassette´s analytical performance, its performance with clinical samples & the manufacturing of reliable sensors.

Expected results and effects:

This project´s expected results were a robust sensor architecture that will be used for clinical and analytical performance evaluation and a compiled Quality and regulatory documentation per ISO13485:2016 for the associated work. Outcome:

As planned, the project led to substantial evidence of feasibility capable of meeting specifications and a simulated sample prototype used for early testing on a design capable of being manufactured within the CoGs structure. Compilation of quality and regulatory documentation for the associated work is ongoing.

Approach and implementation:

Project input: Draft product design input documentation required to define initial cassette storage & transportation conditions.

Project output: Evidence of sensing chemistry feasibility meeting specifications on a design capable of being manufactured within the CoGs structure.

Implementation: ISO13485 accredited contract design, development & the manufacturing company were hired for this project. Their extensive experience has added genuine value to product development, given their expertise in developing & manufacturing in-vitro diagnostic test solutions.