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237
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Wed, 8/11/2021,
10:00 AM -
11:50 AM
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Virtual
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Statistical Challenges in Evaluating Molecular Diagnostic Assays Geared Toward Companion Diagnostics Devices — Topic-Contributed Papers
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Section on Medical Devices and Diagnostics
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Organizer(s): Qin Li, CDRH/FDA
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Chair(s): Xiaoqin Xiong, CDRH/FDA
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10:05 AM
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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
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10:25 AM
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Challenges in the Bridging Study to Validate Companion Diagnostics for Rare Predictive Biomarkers
Dandan Xu, US Food and Drug Administration
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10:45 AM
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Statistical Considerations in Bridging Study for Companion Diagnostic Clinical Validation
Johan Surtihadi, Illumina; Yaji Xu, Illumina; Kristen Meier, Illumina; Joanne Lin, Illumina
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11:05 AM
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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
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11:25 AM
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Discussant: Zhiwei Zhang, NIH
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11:45 AM
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Floor Discussion
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