Extensive validation of microarray-based gene signatures represents the significant challenge in the integration of such information into the standard of care of cancer patient management. Both retrospective and prospective validation, using multiple institutions or in cooperation with clinical trial groups, should be considered in the design of validation studies. In addition, biological pathway analysis and DNA copy number changes can provide a new dimension of data to verify the gene expression-based signatures. To obtain a comprehensive molecular and clinical picture of the patient, the information obtained from these signatures should then be used in concert with standard risk factors as well as data obtained from pathological and clinical evaluations#
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