ROMA (Risk of Ovarian Malignancy Algorithm)
Label Mnemonic: ROMA
Epic Lab Code: LAB8570
Downtime Form: A-1a Miscellaneous Request
Commercial Mail-out Laboratory
5231 RCP
356-8593
Specimen Instructions:
Allow specimen to clot completely at room temperature.
Collection Medium:
Red top tube 5 mL (Clot Activator)
Minimum:
Preferred Minimum: 1.5 mL serum
Absolute Minimum: 1.0 mL serum
Rejection Criteria:
Hemolyzed specimens.
Turn Around Time:
1-8 days upon receipt at reference laboratory
Reference Range:
By Report
Interpretive Data:
The Risk of Ovarian Malignancy Algorithm (ROMA) combines the results of HE4, CA125, and menopausal status into a numerical score. If the patient is premenopausal, then a ROMA score of less than 1.31 is consistent with a low likelihood of having a malignancy on surgery. If the patient is postmenopausal, then a ROMA score of less than 2.77 is consistent with a low likelihood of having a malignancy on surgery.

ROMA is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of having malignancy on surgery. ROMA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening, stand-alone or tumor-monitoring assay. Tumor monitoring using HE4 and/or CA125 should be ordered separately.
Comments:
Ordering Recommendation - Assess cancer risk, particularly epithelial cell ovarian cancer, in pre- and postmenopausal women who present with an adnexal mass. Not intended as a screening, stand- alone, or tumor-monitoring assay. Tumor monitoring using HE4 and/or CA 125 should be ordered separately.
Methodology:
Quantitative Enzyme Immunoassay, Electrochemiluminescent Immunoassay
CPT Code:
86304, 86305