From Technology Transfer to Commercialization : A CDx Collaboration Journey
- Design and development of a kitted IVD assay from a Bioanalytical manual ELISA : a fine balance between inter-operability and successful approvalÂ
- Global registration of the assay in more than 40 countries – not a one-size-fits-all exerciseÂ
- Co-commercialization of a full testing solution across all geographies in alignment with the Drug launch plan i)development, deployment and maintenance of a dedicated Web portal ii) qualification of Lab partners and Logistics service provider iii) design, validation, registration and distribution of a dedicated sample collection kit iv) provision of global customer supportÂ