Online Program

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Friday, September 14
Fri, Sep 14, 9:55 AM - 11:10 AM
Thurgood Marshall South
CMC2: Preclinical/Clinical Safety Evaluation

Statistical Considerations in Companion Diagnostic and Complementary Diagnostic Devices for Precision Medicine (300781)

*Jincao Wu, FDA/CDRH 

Keywords: companion diagnostic, complementary diagnostic, precision medicine

An ongoing paradigm shift in biopharmaceutical research and development aims to incorporate use of novel biomarkers and diagnostic devices to improve safety and efficacy of drugs in more precisely targeted patient populations. Approximately one in five original novel drugs approved by the US FDA since 2010 is considered a “targeted” therapy. Co-development and co-approval of therapeutics and companion diagnostics and complementary diagnostics have provided significant benefits to cancer patients. However, the work in both companion diagnostic and complementary diagnostic tests are relatively new and evolving. With the advent and rapid adoption of next generation sequencing (NGS) technology for biomarker identification and clinical testing, it is conceivable that NGS may soon become the platform of choice to be used for genetic testing of a large array of genes for guiding patients to different targeted therapies. This presentation is intended to provide general discussions of statistical methodologies related to the companion diagnostic and complementary diagnostic devices and statistical issues with emerging diagnostic technologies.