At any point after Phase 1, a project technical and know-how transfer can take place should partners want to continue development themselves or begin parallel assay develop alongside the projects with AgPlus. In such cases, a Development licence can be granted along with the supply of the equipment required and the methods already developed byAgPlus.
Throughout development, a dedicated science and delivery team will be assigned to the project ensuring continuity in development and communication through the process.
AgPlus processes and every stage ofAgPlus technology development are compliant with ISO13485 standards for medical devices. This will aid development partners in the integration of the technology into their required regulatory compliance systems, for example, for CE IVDD and/or FDA approval.
Assay development with AgPlus can typically be segmented into five key phases