Elecsys® HE4 - Human epididymal protein 4

A biomarker for the management of ovarian cancer patients

Elecsys® HE4 - Human epididymal protein 4

A biomarker for the management of ovarian cancer patients

 

The Roche Elecsys® HE4 assay is a tumor marker test for use with blood samples to support monitoring and surveillance of ovarian cancer patients and together with Elecsys® CA 125 II for risk assessment of patients with pelvic mass with the ROMA™ algorithm.

Human epididymal protein 4 (HE4) is a biomarker that is highly elevated in epithelial ovarian cancer and has been shown to be involved in ovarian cancer cell proliferation and invasion1-3

HE4 has a higher sensitivity and specificity than CA 125 in the detection of ovarian cancer in patients presenting with pelvic mass4

In addition, HE4 can be used for monitoring disease and progression.8-10

A combined use of HE4 and CA 125 using ROMA (Risk of Ovarian Malignancy Algorithm) can increase the sensitivity and specificity for assessing the risk of ovarian cancer

 

Among women presenting with pelvic mass, the combined use of HE4 and CA 125 using ROMA (Risk of Ovarian Malignancy Algorithm) can increase the sensitivity and specificity of risk estimation of patients with pelvic mass - even stages I/II ovarian cancer – than CA 125 alone5-7

  • ROMA accurately identifies 94% of the patients with pelvic mass as having ovarian cancer5
  • ROMA has a higher sensitivity than CA 125 alone: Among ten women with ovarian cancer, ROMA identifies one more patient than CA 125 alone (sensitivity: ROMA 90% vs. CA 125 79%)6
  • ROMA has a higher specificity than CA 125 alone: Among ten women with benign gynecologic diseases, ROMA dismisses one more patient which CA 125 alone would include as having ovarian cancer (Specificity: ROMA 93% vs. CA 125 86%)6
  • ROMA has a higher sensitivity and specificity in detecting stages I/II ovarian cancer than CA 125 alone7

 

HE4 and CA 125 together improve ovarian cancer monitoring

 

  • Either HE4 or CA 125 levels can be elevated in patients during therapy monitoring and recurrence monitoring8-10
  • At disease progression, some patients show an elevated HE4 level earlier than an increase in CA 125 level, and others show an elevated CA 125 level earlier than an increase in HE4 level. Therefore, HE4 and CA 125 together can effectively monitor therapy response8-10
  • As patients with elevated CA 125 level at diagnosis can switch to elevated HE4 level at follow up, and vice versa, testing for both HE4 and CA 125 can identify patients with recurrent disease that CA 125 alone would miss10

 

Efficiency and reliability for the laboratory11

 

  • Shows precision across the entire measuring range for reliable results
  • Has 28 days of stability at 2-8˚C after opening
  • Is fast with 18 minute assay time
  • Is available for use in both serum and plasma
  • Consolidation of 17 tumor marker assays is available on one automated platform.
image of a brochure

Risk of Ovarian Malignancy Algorithm (ROMA)

 

The algorithm uses CA 125 value, HE4 value and menopausal status as an aid in estimating the risk of epithelial ovarian cancer in premenopausal and postmenopausal women presenting with pelvic mass.

ROMA™ calculates a predictive probability of finding epithelial ovarian cancer on surgery.

Fujirebio
Pelvic mass evaluation: Risk of Ovarian Malignancy Algorithm (ROMA)6
Pre-menopausal

Post-menopausal

PI = - 12.0 + 2.38*LN[HE4] + 0.0626*LN[CA 125] PI = -8.09 + 1.04*LN[HE4] + 0.732*LN[CA 125]


ROMA* index [%] = exp(PI) / [1 + exp(PI)] *100


< 11.4% ≥ 11.4 %
< 29.9 % ≥ 29.9 %
low risk high risk low risk high risk
s

Elecsys® HE4 - Human epididymal protein 411

  • Assay time

    18 min

  • Sample material

    Serum collected using standard sampling tubes or tubes containing separating gel.
    Li‑heparin, K2‑EDTA and K3‑EDTA plasma.
    Li‑heparin plasma tubes containing separating gel can be used.

     

     

  • Detection limit

    10 μL cobas e 411, cobas e 601 /  e 602
    6 μL cobas e 801

  • Measuring range

    15 - 1,500 pmol/L

  • Intermediate precision

    cobas e 411: 2.7 - 4.3 %
    cobas e 601, cobas e 602: 2.6 - 3.4 %
    cobas e 801: 1.1 - 2.4 %

  • Traceablity

    HE4 EIA from Fujirebio Diagnostics

Note: Approved Intended Use of the assay may vary in different countries. For specific country approved use, please consult your local Package Insert

 

References

 

  1. Moore, R.G. et al. (2012) Scientific Reports 4: 3574
  2. Lu, R. et al. (2012) Biochem. Biophys. Res. Comm. 419: 274-280
  3. Zhu, Y.-F. et al. (2013) Asian Pacific Journal of Tropical Medicine. 265-272 
  4. Moore, R.G. et al. (2008). Gynecol Oncol. 108, 402–408 
  5. Moore, R.G. et al. (2011) Obstet. Gynecol. 118: 280-288 
  6. Ortiz-Muñoz, B. et al. (2014) Tumor Biol. 35(7): 7249-58
  7. Karlsen, M.A. et al. (2012). Gynecol Oncol. 127: 379-383
  8. Schummer, M. et al. (2012) Gynecol. Oncol. 125: 65–69 
  9. Allard, J. et al. (2008) J Clin Oncol. 26 (May 20 Suppl): abstract 5535 
  10. Escudero, J.M. et al. (2014). Tumor Biol. 35 (Suppl 1): S1-S9
  11. Elecsys® HE4 - Human epididymal protein 4 Method Sheet-package insert