Elecsys® CA 125 II

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 HE 4 for risk assessment of patients with pelvic mass with the ROMA algorithm

Elecsys® CA 125 II

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 HE 4 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
  • 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 assessing the risk of 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

Risk of Ovarian Malignancy Algorithm (ROMA)

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Risk of Ovarian Malignancy Algorithm (ROMA)

Pelvic mass evaluation: Risk of Ovarian Malignancy Algorithm (ROMA)


PI = - 12.0 + 2.38*LN[HE4] + 0.0626*LN[CA125] PI = -8.09 + 1.04*LN[HE4] + 0.732*LN[CA125]


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


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

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 for assessing the risk of 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

 

Determining HE4 and CA125 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

 

Technical benefit

 

Efficiency and reliability for the laboratory

  • 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 for use in both serum and plasma

Consolidation of 17 tumor marker assays is available on one automated platform

Elecsys® CA 125 II

  • Assay time

    18 min

  • Sample volume

    20 μL

  • 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

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 1.2016
  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