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Activity Number: 225
Type: Topic Contributed
Date/Time: Tuesday, August 5, 2008 : 8:30 AM to 10:20 AM
Sponsor: Section on Statistics in Epidemiology
Abstract - #302206
Title: Existing Problems in Gene Expression Microarray-Based Assays for Clinical Practice
Author(s): Samir Lababidi*+
Companies: U.S. Food and Drug Administration
Address: 1350 Piccard Drive, HFZ-550, CDRH, Rockville, MD, 20850,
Keywords: Genomic classifier ; gene expression ; microarray ; biomarker ; reproducibility
Abstract:

Genomic classifiers using DNA microarrays are becoming powerful tools in the medical community with the potential to revolutionize the diagnosis and treatment of disease. However, despite the tremendous interest in using these classifiers in diagnosis and the management of disease, few genomic classifiers have made it into clinical practice. At the same time, the explosion of research in genomic technology is setting the ground work for these genomic classifiers to become the major tools for evaluating disease susceptibility, diagnosis, and prognosis. In this presentation we discuss specific existing problems when developing gene expression microarray-based assays during the process of validating the genomic classifier, establishing the reproducibility of the assay, and showing the added benefit of microarray experiment over clinical covariates alone for their use in clinical practice.


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Revised September, 2008