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Aims: To elucidate the expression and regulation of survivin in normal tissues. Methods and results: A novel monoclonal antibody (12C4) to survivin was generated. Application of this antibody to determine survivin expression in human normal adult tissues revealed that most adult tissues do not express survivin and, where it is present, survivin is largely restricted to a small subset of epithelial cells and cells with proliferative potential such as thymus. Survivin expression among positive tissues showed individual variations, ranging from zero to < 5% positive cells in epithelial cell populations. Testis is the only human adult tissue highly expressing survivin, with 60–70% positivity in the nuclei of spermatogonia. Consistent with deregulated expression of survivin associated with oncogenesis, we found that certain ligands and transcription factors differentially modulate survivin promoter activity in cancer cells versus normal/untransformed cells. Conclusion: Deregulation of survivin transcription controls in individual epithelial cells may contribute to oncogenesis in various human adult tissues. [ABSTRACT FROM AUTHOR]