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237 Wed, 8/11/2021, 10:00 AM - 11:50 AM Virtual
Statistical Challenges in Evaluating Molecular Diagnostic Assays Geared Toward Companion Diagnostics Devices — Topic-Contributed Papers
Section on Medical Devices and Diagnostics
Organizer(s): Qin Li, CDRH/FDA
Chair(s): Xiaoqin Xiong, CDRH/FDA
10:05 AM Statistical Considerations in Bridging Study of Personalized Medicine with Biomarker-Based Prescreened Samples
Wei Wang, US Food and Drug Administration; Rajesh R Nair, CDRH/FDA
10:25 AM Challenges in the Bridging Study to Validate Companion Diagnostics for Rare Predictive Biomarkers
Dandan Xu, US Food and Drug Administration
10:45 AM Statistical Considerations in Bridging Study for Companion Diagnostic Clinical Validation
Johan Surtihadi, Illumina; Yaji Xu, Illumina; Kristen Meier, Illumina; Joanne Lin, Illumina
11:05 AM Statistical Methods for PPV Confidence Interval Estimation for Clinical Bridging Studies When PPV Is Near or at 100%
Meijuan Li, Foundation medicine; Lei Yang, Foundation medicine; Chang Xu, Foundation medicine; Cui Guo, Foundation medicine
11:25 AM Discussant: Zhiwei Zhang, NIH
11:45 AM Floor Discussion