Study design and statistical considerations/challenges for “Me Too” companion diagnostics
*Meijuan Li, US Food and Drug Administration 


It is a current trend that diagnostic testing is used to select patients for corresponding therapeutic products which involves both therapeutic products and companion diagnostic devices. With the rapid development in the area of personalized medicine, and a number of FDA-approved companion diagnostics for use with specific corresponding therapeutic products, opportunities exit for device companies to develop follow-on companion diagnostic devices, which also are called “Me Too” companion diagnostic devices. These follow-on companion diagnostic devices seek the same therapeutic indication as a FDA-approved companion diagnostics. There are many challenges associated with the validation of these devices, including patient sample availability, the lack of therapeutic partner, etc. In this talk, we will discuss the study design and statistical considerations/challenges for the clinical validation of “Me Too” companion diagnostics.