ROMA™ (Risk of Ovarian Malignancy Algorithm) [91155]

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Test Code

Alias/See Also

CPT Codes

CA125, HE4 Ovarian CA Monitoring, and Risk of Ovarian Malignancy calculation

Preferred Specimen
1 mL serum collected in a red-top tube (no gel)

Minimum Volume
0.5 mL

Sample collected in red-top tube must be allowed to clot for at least 30 minutes but no longer than 1 hour.

Transport Temperature

Specimen Stability
Room temperature: 24 hours
Refrigerated: 72 hours
Frozen: 28 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Moderate to gross hemolysis • Lipemia • Icteric • Presence of fibrin • Red blood cells • Other particulate matter • Obvious microbial contamination

Calculation (CALC) • Chemiluminescent Microparticle Immunoassay (CMIA)

Setup Schedule
Set up: Tues, Thurs, Sat; Report available: 3-5 days

Reference Range
ROMA Premenopausal <1.31
ROMA Postmenopausal <2.77
CA125 <35 U/mL
HE4, Ovarian CA Monitoring  
  Female Premenopausal ≤70 pmol/L
  Female Postmenopausal ≤140 pmol/L

Clinical Significance
The risk of Ovarian Malignancy Algorithm (ROMA™) test is intended to aid in assessing the risk of ovarian cancer in women with a pelvic mass based on the patient's HE4 and CA125 levels, and their menopausal status. Women with ROMA™ levels above the cutoff have an increased risk of ovarian cancer. ROMA™ must be interpreted in conjunction with an independent clinical and radiological assessment.

The ROMA™ test is indicated for women who meet the following criteria:
over age 18; presence of an ovarian pelvic mass for which surgery is planned; and not yet referred to an oncologist.

The CA125 and HE4 tests are performed using the Abbott ARCHITECT i2000SR unit. The values obtained with different assay methods cannot be used interchangeably due to differences in assay methods and reagent specificity.

The test is not intended as a screening stand-alone diagnostic or tumor monitoring assay. Tumor monitoring using HE4 and/or CA125 should be ordered separately.

The ROMA value is the result of a computation based on the HE4 and CA125 values observed.
1. Moore RG, et al. A novel multiple marker bioassay utilizing HE4 and CA 125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol 2009; 112:40-6.

Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042

Last Updated: May 18, 2022

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.