Elecsys® CA 125 II

  • CA 125 is found in a high percentage of ovarian tumors of epithelial origin1-2
  • CA 125 is widely known in international guidelines for use in pelvic mass evaluation and in therapy and recurrence monitoring of ovarian cancer3-5
  • 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 detecting ovarian cancer - even stages I/II ovarian cancer – as compared to testing CA 125 alone6-8
  • In addition, HE4 complements CA 125 in identifying patients with disease recurrence and disease progression9-11

ROMA
Elecsys CA 125

Risk of Ovarian Malignancy Algorithm (ROMA) with Elecsys HE4 and CA 125 II

Accurate stratification of women with stage I-IV ovarian cancer:

83.3% were correctly classified as high risk
75.6% were correctly classified as low risk
Positive predictive value of 65%
Negative predictive value of 90%

Elecsys CA 125 II
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 as well as plasma tubes
Sample volume 20 µL
Detection Limit* LoB 0.6 U/mL
Measuring Range 0.6 - 5000 U/mL
Traceablity Enzymun-Test CA 125 II method

*LoB = Limit of Blank

Clinical benefit #1: Among women presenting with pelvic mass, a combined use of HE4 and CA 125 using ROMA (Risk of Ovarian Malignancy Algorithm) can increase the sensitivity and specificity of detecting ovarian cancer - even stages I/II ovarian cancer – as compared to testing CA 125 alone

  • ROMA accurately identifies 94% of the patients with pelvic mass as having ovarian cancer6
  • 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%)7
  • ROMA has a higher specificity than CA 125 alone: Among ten women with benign gynecologic diseases, ROMA dismisses one more patient which CA125 alone would include as having ovarian cancer (Specificity: ROMA 93% vs. CA 125 86%)7
  • ROMA has a higher sensitivity and specificity in detecting stages I/II ovarian cancer than CA 125 alone8

Clinical benefit #2: CA 125 and HE4 together improve ovarian cancer monitoring

  • Either HE4 or CA 125 levels can be elevated in patients during therapy monitoring and recurrence monitoring9-11
  • 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 response9-11
  • 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 miss11

Technical benefit: Efficiency and reliability for the laboratory

  • Elecsys® CA 125 II
    • Shows excellent precision across the entire measuring range for reliable results
    • Uses a low sample volume (20 ul) 
    • Is fast with 18 minute assay time
    • Is available or use in both serum and plasma
  • Consolidation of 17 tumor marker assays is available on one automated platform
References

1. Clarke-Pearson, D.L. (2009) NEJM 361-2
2. Kabawat S.E. (1983) Am. J. Clin. Pathol. 79: 98-104 
3. NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Ovarian Cancer Including Fallopian Tube Cancer and Primary Periotoneal Cancer. Version 2.2014
4. NICE (National Institute for Health and Clinical Exellence) Clinical Guideline: Ovarian Cancer: The Recognition and Initial Management of Ovarian Cancer, issued April 2011. NICE Clinical Guideline 122.
5. Ledermann J.A. et al. (2013) Annals of Oncology 24 (Supplement 6): vi24–vi32, 2013 
6. Moore, R.G. et al. (2011) Obstet. and Gynecol. 118: 280-288
7. 
Ortiz-Muñoz, B. et al. (2012) Tumor Biol. 35(7): 7249-58
8. 
Karlsen, M.A. et al. (2012). Gynecol. Oncol. 127: 379-383 
9. 
Schummer, M. et al. (2012) Gynecol. Oncol. 125: 65–69 
10. 
Allard, J. et al. (2008) J. Clin. Oncol. 26 (May 20 Suppl): abstract 5535 
11. 
Escudero, J.M. et al. (2014). Tumor Biol. 35 (Suppl 1): S1-S9