Available Assays and Interpretation

The prognostic significance of TP53 status in breast cancer has been affected by the accuracy of IHC methods compared to molecular methods (single strand conformational polymorphism [SSCP], direct sequencing, microarray sequencing chip, and yeast colony functional assay) to identify TP53 mutations.7273 IHC evaluations with and without image analysis-assisted slide scoring using either the DO-1 or the PAb1801 antibodies have yielded variable associations between TP53 stabilized mutant protein nuclear staining and outcome in breast cancer. In general, the DO-1 antibody has been favored by some investigators over the PAb1801;74 however, the high number of false-positive and false-negative IHC results (compared with gene sequencing) precludes reliable use of IHC as an indicator for TP53 gene mutation status in human breast cancer.75

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