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Human Epididymis Protein 4

CA 125 is the most commonly used serum marker to monitor therapeutic response and detect disease recurrence in patients treated for epithelial ovarian cancer. The National Comprehensive Cancer Network recommends CA 125 measurement before each treatment cycle and at each follow-up evaluation for women with elevated pretreatment concentrations. However, CA 125 is not elevated in all patients with epithelial ovarian cancer and is not specific for ovarian cancer. For this reason, physicians measure Human Epididymis Protein 4 (HE4) in addition to CA 125.3

HE4 was first identified in the epithelium of the distal epididymis and originally predicted to be a protease inhibitor involved in sperm maturation. HE4 is overexpressed in 93 percent of serous, 100 percent of endometrioid epithelial ovarian cancers, and 50 percent of clear cell (not mucinous) ovarian carcinomas. HE4 is secreted into the circulation resulting in elevated serum levels.

HE4 is used to monitor recurrence of progressive disease in patients with epithelial ovarian cancer. Serial measurement HE4 can be used in conjunction with CA-125 and other clinical methods to monitor patients with known ovarian cancer for disease progression or therapeutic response. HE4 increases by 25 percent or greater in 60 percent of women with ovarian cancer relapse or progression. A decrease of this magnitude suggests therapeutic response. HE4 remains constant in 75 percent of women without disease progression.

Mucinous and germ-cell tumors of the ovary rarely express HE4. Therefore, HE4 is not recommended for monitoring of patients with these types of ovarian cancer.

An elevated HE4 concentration is not specific for ovarian cancer. HE4 may be elevated in other types of adenocarcinoma (breast, lung, GI and endometrial), pregnancy and in benign gynecological conditions. It should not be used to screen for ovarian cancer in asymptomatic women.

Reference range is 0-150 pmol/L using the HE4 enzyme immunometric assay from Fujirebio Diagnostics, Inc. Values obtained with different immunoassay methods should not be compared. Specimen requirement is a plain red or serum separator tube.

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