Biomarker: HE4 (Human Epididymis protein 4)

What is HE4 (Human Epididymis protein 4)?

  • HE4 was first identified as a specific protein of the human epididymis by Kirchoff et al in 1991

  • Over-expression in ovarian tissue was observed by Schummer et al in 1999

  • The utility of HE4 as a serum biomarker in ovarian cancer was then described by Hellström et al in 2002

HE4 is expressed in the glandular epithelium of the reproductive tract, distal renal tubules and respiratory epithelium, however the highest serum levels of HE4 are found in epithelial and serous ovarian cancer and also endometrioid cancer.

HE4 has been found to be raised in ovarian cancer patients who did not have elevated CA125 levels and HE4 is not elevated in benign gynaecological conditions, e.g. pregnancy, menstruation, endometriosis.

HE4 is not evelevated

  • during pregnancy2
  • in any phases of the menstruation cycle or with hormonal treatments3
  • with hormonal stimulation during IVF treatment4

Importance of specific biomarker for management of gynecologic diseases

Cysts are a common occurrence, especially in premenopausal women, and the majority of cysts are benign:

  • Up to 10% of women will have some form of surgery for ovarian mass5
  • Preoperative differentiation between the benign and the malignant ovarian mass in the premenopausal woman is problematic6

Lumipulse® G HE4 (Human epididymis protein 4)

Lumipulse G HE4 is a Chemiluminescent Enzyme Immunoassay (CLEIA) for in vitro diagnostics (IVD) use for the quantitative measurement of HE4 (Human epididymis protein 4) in human serum or plasma on the LUMIPULSE G system.

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