Human Epididymis protein 4 (HE4) has recently been shown to improve the sensitivity and specificity of Epithelial Ovarian Cancer (EOC) diagnosis but its function in cancer cells is not clear. We evaluated HE4 expression, RMI and CA125 serum level as diagnostic tools of primary ovarian cancer in Egyptian women. The HE4 gene expression was evaluated by real time PCR in ovarian cancer of 50 Egyptian women. Ovarian cancer tissues were studied for the detection of the gene expression of HE4 by Quantitative Real Time PCR (Q RT-PCR). Serum Human cancer antigen 125 (CA 125) was measured in the serum of all participants of the study using immune sorbent assay (ELISA). The HE4 showed significant difference among ovarian malignant tumors patients compared to the control subjects (p<0.01). The best cutoff value 0.053 at which HE4 sensitivity was 92% and specificity was 96%. There was a significance correlation between HE4, RMI and CA125 in all patients of the study (p#0.01 for both). The mRNA expression of HE4 was significantly high versus the control group in early stages and low grades of the disease (p = 0.00, 0.01, respectively). As well as, there was Increased HE4 expression in the late stages of the disease suggesting that it may be associated with poor prognosis as well. The HE4 could be considered as a good prognostic marker for ovarian cancer that increases the sensitivity of the CA 125 to absolute value without affection of CA125 accuracy and its positive predictive value.

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