In phase 2, suppliers will develop prototype of designed solution and demonstrate its analytical validity. Analytical validation will consist in demonstrating of assay performance (accuracy, precision, specificity, etc.).
During Phase 2, suppliers will be required to deliver the clinical performance assessment protocol of the precommercial devices, and Data Management Plan they will perform in Phase 3.
At the end of the Phase 2, a call-off for Phase 3 will be issued and the two most successful suppliers will be invited to submit a bid.
Overall duration: 15 months
Execution : 12 months