The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring response to therapy for patients with invasive epithelial ovarian cancer.
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 HE41.
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 alone2.
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.