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HelpTest Code ROMA ROMA Score (Ovarian Malignancy Risk Algorithm), Serum
Useful For
Risk assessment for finding an ovarian malignancy during surgery in women who present with an adnexal mass
The test is not intended as a screening or stand-alone diagnostic assay for ovarian cancer.
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HE4R | HE4,S | Yes, (Order HE4) | Yes |
| CA125 | Cancer Ag 125 (CA 125), S | Yes, (Order CA25) | Yes |
| ROMA1 | Risk Score, if premenopausal | No | Yes |
| ROMA2 | Risk Score, if postmenopausal | No | Yes |
Method Name
Reporting Name
ROMA ScoreSpecimen Type
SerumSpecimen Required
Patient Preparation: Patients receiving therapy with high biotin doses (ie, >5 mg/day) should not have their specimen collected until at least 8 hours after the last biotin administration.
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Specimen Minimum Volume
0.75 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 84 days | |
| Refrigerated | 48 hours |
Reference Values
Males: Not applicable
Females:
HUMAN EPIDIDYMIS PROTEIN 4≤140 pmol/L
CANCER ANTIGEN 125 <46 U/mL
ROMA SCORE
Premenopausal: <1.14 (low risk)
Postmenopausal: <2.99 (low risk)
Interpretation
In premenopausal women, a risk of ovarian malignancy algorithm (ROMA) value of 1.14 or greater indicates a high risk of finding epithelial ovarian cancer, whereas a ROMA value less than 1.14 indicates a low risk of finding epithelial ovarian cancer at surgery.
In postmenopausal women, a ROMA value of 2.99 or greater indicates a high risk of finding epithelial ovarian cancer, whereas a ROMA value less than 2.99 indicates a low risk of finding epithelial ovarian cancer at surgery.
The use of these cut-points provides a 75% specificity and sensitivity of 84% in patients with stage I-IV epithelial ovarian cancer.
Clinical Reference
1. Dochez V, Caillon H, Vaucel E, Dimet J, Winer N, Ducarme G. Biomarkers and algorithms for diagnosis of ovarian cancer: CA125, HE4, RMI and ROMA, a review. J Ovarian Res. 2019;12(1):28. doi: 10.1186/s13048-019-0503-7. PMID: 30917847; PMCID: PMC6436208
2. Moore RG, Jabre-Raughley M, Brown AK, et al: Comparison of a novel multiple marker assay vs the Risk of Malignancy Index for the prediction of epithelial ovarian cancer in patients with a pelvic mass. Am J Obstet Gynecol. 2010;203(3):228.e1-6
3. Karlsen MA, Sandhu N, Hogdall C, et al. Evaluation of HE4, CA125, risk of ovarian malignancy algorithm (ROMA) and risk of malignancy index (RMI) as diagnostic tools of epithelial ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2012;127(2):379-383
Day(s) Performed
Monday through Friday
Report Available
1 to 3 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
86305-HE4, S
86304-Cancer Ag 125 (CA 125), S
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| ROMA | ROMA Score | 104551-7 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| HE4R | HE4,S | 55180-4 |
| CA125 | Cancer Ag 125 (CA 125), S | 83082-8 |
| ROMA1 | Risk Score, if premenopausal | 69569-2 |
| ROMA2 | Risk Score, if postmenopausal | 69570-0 |
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.