|
|
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
|