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 HE 4 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, HE 4 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 HE 4 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 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

 

Clinical benefit #2

 

Determining HE 4 and CA125 independently can improve ovarian cancer monitoring

  • Either HE 4 or CA 125 levels can be elevated in patients during therapy monitoring and recurrence monitoring9-11
  • At disease progression, some patients show an elevated HE 4 level earlier than an increase in CA 125 level, and others show an elevated CA 125 level earlier than an increase in HE 4 level. Therefore, HE 4 and CA 125 together can effectively monitor therapy response9-11
  • As patients with elevated CA 125 level at diagnosis can switch to elevated HE 4 level at follow up, and vice versa, testing for both HE 4 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