Description: The major discussion will be focused on US regulations and clinical research considerations for the IVD in CDx. The current CDx types. Keeping informed of CDx regulations and product development requirements helps us to protect those human subjects, preserve the integrity of the data, execute the best appropriate study design and obtain the regulatory approval.
Learning Objectives:
Upon completion, participants will be able to understand the complexity of Companion Diagnostics in clinical investigations.
Participants will be able to describe the therapeutic segment of the companion diagnostic investigations as it pertains to product development and intended use in planning a clinical study for submission
Upon completion, participants will be able to define traditional tissue IHC/ISH companion diagnostics and up and coming Next Generation Sequencing