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Contributed Papers

Advancing Diagnostic Evidence: New Metrics, Robust Inference, and Practical Standards for Biomarker Evaluation and Molecular Diagnostics

Sun, Aug 2, 4:00 PM - 5:50 PM Room CC-254A Thomas M. Menino Convention & Exhibition Center

Estelle Russek-CohenChair

Section on Medical Devices and Diagnostics

7 Presentations

A Novel Approach for Biomarker Evaluation in Binary Classification

4:05 PM - 4:20 PM

Xiaoyi Ma (SUNY at Buffalo)

Co-authors: Lili Tian (SUNY At Buffalo)

Biomarker evaluation Diagnostic studies ROC analysis

A summary measure of the ROC curve using its derivative for biomarker accuracy evaluation

4:20 PM - 4:35 PM

Maria Pardo (Complutense University of Madrid)

Co-authors: Alba Franco-Pereira (Complutense University of Madrid)

ROC summary indexes Binormal ROC curve Box-Cox transformation Bootstrap Kernel

Empirical likelihood inference for the area under the ROC curve with verification biased data

4:35 PM - 4:50 PM

Gengsheng Qin (Georgia State University)

Co-authors: Shirui Wang (Georgia State University), Shuangfei Shi (Georgia State University)

Receiver operating characteristic (ROC) curve;Area under the ROC curve (AUC);Verification bias;Missing at random;Empirical likelihood;Diagnostic tests

Improving efficiency of AUC estimation in randomized trials through covariate adjustment

4:50 PM - 5:05 PM

Monica Colon Vargas

Co-authors: Jon Steingrimsson (Brown University)

AUC covariate adjustment efficiency randomized control trial

Two-Cutpoint Youden Index Inference under Verification Bias

5:05 PM - 5:20 PM

Co-authors: Gengsheng Qin (Georgia State University), Li-Hsiang Lin (Georgia State University)

Two-Cutpoint Youden Index Verification Bias Missing at Random Double Robustness Diagnostic Accuracy Bootstrap Inference

Statistical Methods for Comparing Limits of Detection in Molecular Diagnostics: A Practical Guide

5:20 PM - 5:35 PM

Jesse Canchola (Roche Diagnostics Solutions)

Co-authors: Brahian Cano Urrego (University of Kansas Medical Center ASA Student Chapter)

Limit of detection (LoD)Molecular diagnostics Equivalence testing (TOST)Non-inferiority testing Bootstrap inference Multi-target assays

Global Variability in Pediatric Hepatic Reference Ranges Using International RWD

5:35 PM - 5:50 PM

Linyun Zhou (Takeda)

Co-authors: John Marcinak M.D. (AbbVie), Sherri Matis-Mitchell Ph.D. (AstraZeneca), William Treem M.D. (UNO Consulting Services, LLC), Bazle Abidi M.D. (Amgen), Linda Wang M.D. (Gilead Sciences), Girish Rao M.D. (Eli Lilly and Company), Ariel Ramirez Porcalla M.D. (AbbVie)

Safety monitoring Data visualization Real-world data Pediatric laboratory reference ranges Drug-induced liver injury Mixed Model with Random Effects

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