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
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.9-11
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.10,12
ROMA™ calculates a predictive probability of finding epithelial ovarian cancer on surgery.10,12
Pelvic mass evaluation: Risk of Ovarian Malignancy Algorithm (ROMA)10 | |||
Pre-menopausal ▼ |
Post-menopausal ▼ |
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PI = - 12.0 + 2.38*LN[HE4] + 0.0626*LN[CA 125] | PI = -8.09 + 1.04*LN[HE4] + 0.732*LN[CA 125] | ||
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ROMA* index [%] = exp(PI) / [1 + exp(PI)] *100 | |||
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< 11.4% | ≥ 11.4 % |
< 29.9 % | ≥ 29.9 % |
low risk | high risk | low risk | high risk |
*Human samples only
Note: Approved Intended Use of the assay may vary in different countries. For specific country approved use, please consult your local Package Insert
References