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693 * ! | Thu, 8/13/2015, 10:30 AM - 12:20 PM | CC-612 | |
Evaluation of In Vitro Diagnostics — Contributed Papers | |||
Section on Medical Devices and Diagnostics | |||
Chair(s): Li Zhou, Abbot | |||
10:35 AM | Statistical Considerations in Clinical Studies Supporting Blood Donor Screening Assays — Zhen Jiang, FDA | ||
10:50 AM | Use of Gray Zone in IVD Tests — Tie-Hua Ng, FDA/CBER ; Paul Hshieh, CBER/FDA | ||
11:05 AM | Statistical Issues in Evaluating Prostate-Specific Antigen Test for Aid in Prostate Cancer Detection — Kyungsook Kim, FDA | ||
11:20 AM | Is HemoGenix Assay HALO 96 PCAEQ Really CFU-Equivalent Progenitor Cell Assay? — Pingfu Fu, Case Western Reserve University ; Jane Reese, Case Western Reserve University ; Brittney Hooper, Case Western Reserve University | ||
11:35 AM | Error Grid Analysis (EGA) of Glycated Hemoglobin A1c: A Proposed Method — Jesse Canchola, Roche Molecular Systems, Inc. ; Shivani Aggarwal, University of Southern California | ||
11:50 AM | Statistical Evaluation of the Analytic Performance of a Clinical Sequencing Assay — Eric Polley, National Cancer Institute ; Lun-Ching Chang, National Cancer Institute | ||
12:05 PM | Classifying Usual Interstitial Pneumonia in Patients with Interstitial Lung Disease Using Machine Learning on High-Dimensional Transcriptional Data — Su Yeon Kim ; James Diggans, Veracyte, Inc. ; Dan Pankratz, Veracyte, Inc. ; Jing Huang, Veracyte, Inc. ; Moraima Pagan, Veracyte, Inc. ; Nicole Sindy, Veracyte, Inc. ; Yoonha Choi, Veracyte, Inc. ; Giulia C. Kennedy, Veracyte, Inc. |
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