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CC = Baltimore Convention Center,    H = Hilton Baltimore
* = applied session       ! = JSM meeting theme

Activity Details

471 * Wed, 8/2/2017, 8:30 AM - 10:20 AM CC-320
Statistical Methods and Challenges in Diagnostic Medicine — Contributed Papers
Section on Medical Devices and Diagnostics , Section on Statistics in Genomics and Genetics
Chair(s): Allison Meisner, University of Washington
8:35 AM Passing-Bablok Regression Analysis with Rank-Transferred Data in Evaluating Hemostasis State of a Blood Sample Kyungsook Kim, FDA
8:50 AM Essential Statistical Methods for Molecular Diagnostics Jesse Albert Canchola, Roche Molecular Systems Inc. ; Pari Hemyari, Roche Molecular Systems Inc.
9:05 AM Probability of Detection of Target Nucleic Acid Sequence with PCR Assay in Molecular Diagnostics: Math Model Derivation, Validation and Applications Jeffrey Vaks, Roche Molecular Diagnostics
9:20 AM Variant Call Differences Between Paired Reads in Illumina Amplicon Sequencing: An Issue for Rare Mutation Detection Wei-Min Liu, Roche Molecular Systems Inc. ; Julie Chen, UC Berkeley
9:35 AM Statistical Considerations in Clinical and Analytical Validations for Next Generation Sequencing Based GeneticTests Jincao Wu, Food and Drug Administration ; Meijuan Li, CDRH/FDA
9:50 AM Inferences from Various Study Designs for Companion Diagnostic Device Evaluation Jeng Mah, Beckman Coulter
10:05 AM Companion Diagnostic Device Partial Bridging Study in Precision Medicine - Challenges and Methods Yaji Xu, FDA/CDRH
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