The HE4 EIA is a solid-phase, non-competitive immunoassay based upon the direct sandwich technique using two mouse monoclonal antibodies, 2H5 and 3D8, directed against two epitopes in the C-WFDC domain of HE4 (1).
HE4 is a serum biomarker that when combined with CA125™ significantly raises the level of sensitivity for the determination of risk of malignancy in patients presenting with a pelvic mass. HE4 is consistently expressed in patients with ovarian cancer, and it has demonstrated increased sensitivity and specificity over that of CA125 alone (2).
- Hellström I, et al. The HE4 (WFDC2) protein is a biomarker for ovarian carcinoma. Cancer Res. 2003; 63: 1999-2003.
- Moore R, et al. The use of multiple novel tumor biomarkers for the detection of ovarian carcinoma in patients with a pelvic mass. Gynecol Oncol. 2008; 108: 402-408.
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