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Test ID ROMA ROMA Score (Ovarian Malignancy Risk Algorithm), Serum


Specimen 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.


Secondary ID

62661

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

Reporting Name

ROMA Score

Specimen Type

Serum

Specimen Minimum Volume

0.75 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen (preferred) 84 days
  Refrigerated  48 hours

Clinical Information

Women with ovarian cancer symptoms and adnexal masses present primarily to gynecologists, primary care physicians, or general surgeons. Triage guidelines from the American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists recommend referral of women with a pelvic mass at high risk for ovarian cancer to gynecologic oncologists. Specialized treatment improves patient outcomes resulting in fewer complications and better survival rates when compared to patients treated by surgeons less familiar with the management of ovarian cancer.

 

The risk of ovarian malignancy algorithm (ROMA) incorporates cancer antigen 125 (CA125), human epididymal protein 4 (HE4), and menopausal status to assign women that present with an adnexal mass into a high-risk or low-risk group for finding an ovarian malignancy. ROMA is indicated for women who meet the following criteria: older than age 18, presenting with an adnexal mass for which surgery is planned, and who have not yet been referred to an oncologist. ROMA must be interpreted in conjunction with clinical and radiological assessment.

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)

Cautions

The risk of ovarian malignancy algorithm (ROMA) test should not be used without an independent clinical/radiological evaluation and is not intended to determine whether a patient should proceed to surgery. A low-likelihood ROMA result in the setting of a positive initial cancer risk assessment should not preclude an oncology referral.

 

ROMA has not been validated for the following groups: women previously treated for malignancy, women currently being treated with chemotherapy, pregnant women, or women younger than age 18.

 

Serum markers are not specific for malignancy and values may vary by method. Values obtained with different assay methods cannot be used interchangeably.

 

In rare cases, interference due to extremely high titers of antibodies to specific reagents (human antimouse antibody or heterophile antibodies, streptavidin or ruthenium) can occur. The laboratory should be alerted if result does not correlate with the clinical presentation.

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Performing 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

NY State Approved

Yes