A Regulatory Perspective on the Evaluation Companion Diagnostic Devices for Targeting Therapy
*Thomas E Gwise, Center for Devices and Radiological Health, FDA 

Keywords: Biomarker, Diagnostic, Device

Personalized medicine promises treatments targeted to individual patients based on some individual characteristics, such as genomic or proteomic information. The characteristic or biomarker which defines the indicated population is often identified using a medical diagnostic device. Designing clinical trials that thoroughly evaluate both the treatment and the diagnostic test can be challenging. This presentation will discuss some of the challenges FDA statisticians face in reviewing diagnostic tests for personalized medicine applications.