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
