JSM 2004 - Toronto

Abstract #300288

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Activity Number: 394
Type: Invited
Date/Time: Thursday, August 12, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #300288
Title: Effectively Developing and Evaluating Medical Diagnostics Based on Whole Genome Technologies
Author(s): Richard Simon*+
Companies: National Institutes of Health
Address: National Cancer Institute, Bethesda, MD, 20892-7434,
Keywords: microarrays ; pharmacogenomics ; diagnostic ; classification
Abstract:

Whole genome technologies, such as RNA transcript profiling, SNP genotyping, and proteomics spectral characterization, are providing new tools which will have major influence on the future of medicine. The effective utilization of these technologies requires inter-disciplinary collaboration among clinical investigators, basic scientists, and statisticians. Today there are many growing pains in the use of these technologies and substantial misinformation about the design and analysis of related studies.These problems threaten to seriously delay the utilization of whole genome technologies for improving public health. Misunderstanding of the principles for development of medical diagnostics based on whole genome technologies can result in inadequate studies and inappropriate regulatory policies. I will present an overview of the use of DNA microarray technology for predicting response to treatment. I will indicate how microarray technology has the potential to rapidly expedite the development of such diagnostic tests and identify the essential components in the design and analysis of studies for development and evaluation of microarray-based diagnostics.

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Revised March 2004