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CC = Colorado Convention Center   H = Hyatt Regency Denver at Colorado Convention Center
* = applied session       ! = JSM meeting theme

Activity Details

410 Tue, 7/30/2019, 2:00 PM - 3:50 PM CC-104
Diagnostic Tests: Regulatory Considerations of Intermediate Outputs and Oncology Screening, and Optimal Point of Heterogeneous ROC Curves — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Alan M. Zaslavsky, Harvard Medical School
2:05 PM Evaluation of Diagnostic Tests with Binary/Dichotomous Output: a Decision Analytic Approach
Arianna Simonetti, U.S. Food and Drug Administration - CDRH; Bipasa Biswas, U.S. Food and Drug Administration - CDRH
2:20 PM Diagnostic Devices with Intermediate/Gray Zone Output
Bipasa Biswas, U.S. Food and Drug Administration - CDRH
2:35 PM ROC Analysis for Multistage Diagnostic Testing Procedures in the Presence of Indeterminate Results
Ziqiang Chen, State University of New York At Buffalo; Gregory Wilding, SUNY at Buffalo
2:50 PM Statistical Methods to Address Verification Bias for Evaluating Screening Tests

Changhong Song, FDA
3:05 PM Uncertainty of the Reported Results in Molecular Diagnostics

Jeffrey Vaks, Roche Molecular Diagnostics
3:20 PM The Optimal Point of the ROC Curve When Disease Distribution Is a Mixture of Normals
Donna McClish, VCU
3:35 PM Floor Discussion