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This parallel study was designed to compare the sensitivity and specificity of detection of point mutations in fresh-frozen and formalin-fixed, paraffin-embedded breast cancer tissue. Sequence analysis of exon 5 of p53 gene was performed on polymerase chain reaction-amplified DNA from 25 infiltrating ductal carcinomas of the breast. Four tumors showed mutations with identical base substitutions in their respective codons of both frozen and paraffin-embedded specimens. We conclude that subtle genetic alterations can be detected in archival paraffin tissue with an accuracy comparable to that of fresh-frozen histologic samples.