A French based company asked Fleet to develop an automation-ready assay for a second generation test to replace their previous assay. The 18 month study involved raw material investigation, prototype assay development and then full performance verification studies of the selected assay design vs. agreed product requirements documentation.
The project was broken down into four phases:
Phase 1: Product Requirements Definition.
Phase 2: Prototype Assay Development.
Phase 3: Assay Optimisation and Clinical Performance Verification.
Phase 4: Demonstration of Assay Robustness and Raw Material Supply Activities.
The resulting assay met all performance goals after close collaboration between scientists in both companies.