Companion Diagnostics
CDx solutions with GenDx: Your partner from start to finish
Our development strategy
Our dedicated project team will work closely with you to ensure that every aspect of the project aligns with your specific requirements and the applicable legislation. This project team can and will support you during the different stages of your CDx development project. Every project starts with a fully customized project design, fitted to your requirements, which will be the basis of the project. From there on GenDx can guides and supports you from concept, through the different stages, to clinical implementation of CDx.
Our short, internal communication lines will ascertain that the assay development is in line with all regulatory requirements for the eventual clinical performance studies and or CDx registration. Moreover, through the combination of our expertise and our strong and robust network of collaborators, we can support your project in all different aspects, from the development and submission of Performance Study Applications to Clinical Operations and CDx registration.
