Search

Elecsys® CA 125 II

A biomarker for the management of ovarian cancer patients

Elecsys® CA 125 II
A biomarker for the management of ovarian cancer patients

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

  • CA 125 is found in a high percentage of ovarian tumors of epithelial origin1-2
  • CA 125 is widely mentioned in international guidelines for use in pelvic mass evaluation and in therapy and recurrence monitoring of ovarian cancer3-5
  • In addition, HE4 complements CA 125 in identifying patients with disease recurrence and disease progression9-11

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, 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 - even stages I/II ovarian cancer – as compared to testing CA 125 alone.6-8

  • 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 CA 125 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

 

Determining HE4 and CA 125 independently can 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

 

Efficiency and reliability for the laboratory12

 

  • Shows precision across the entire measuring range for reliable results
  • Uses a low sample volume (20 uL cobas e 411, cobas e 601 / e 602 and 12 uL on cobas e 801)
  • 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

Related information

Contact Us
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.

ROMA calculator
Fujirebio

View Full Table
close

Pelvic mass evaluation: Risk of Ovarian Malignancy Algorithm (ROMA)7
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
HCP talking to patient

Elecsys® CA 125 II12

  • Assay time

    18 min

  • Sample volume

    20 μL cobas e 411, cobas e 601 /  e 602
    12 μL cobas e 801

  • Detection limit*

    LoB 0.6 U/mL

  • Measuring range

    0.6 – 5000 U/mL

  • Traceability

    Enzymun-Test CA 125 II method

  • Sample material

    Serum collected using standard sampling tubes or tubes containing separating gel
    Li-herapin, K2-EDTA and K3-EDTA plasma as well as plasma tubes

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. 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 1.2020
  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. (2014) 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
  12. Elecsys® CA 125 II Method Sheet-package insert