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Test Code ROMA Ovarian Malignancy Risk Algorithm

Secondary ID

62661

Useful For

As an aid in assessing whether there is a high- or low- likelihood of finding an ovarian malignancy at surgery in women who present with an adnexal mass

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 Required


Patient Preparation: Specimens should not be collected from patients receiving therapy with high biotin doses (ie, >5 mg/day) until at least 8 hours following the last biotin administration.

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL


Specimen Minimum Volume

0.50 mL

Specimen Stability Information

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

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross OK

Icterus

NA

Other

NA

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 Gynecologist and the Society of Gynecologic Oncologists recommends 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 CA125, 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: are older than age 18, present with an adnexal mass for which surgery is planned, and have not yet referred to an oncologist. ROMA must be interpreted in conjunction with clinical and radiological assessment.

Reference Values

Females:

HE4, S

≤140 pmol/L

Cancer Ag 125 (CA 125), S

<46 U/mL

ROMA Score

Premenopausal: <1.14 (low risk)

Postmenopausal: <2.99 (low risk)

Males: Not applicable

Interpretation

In a premenopausal women a risk of ovarian malignancy algorithm (ROMA) value equal to or greater than 1.14 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 a postmenopausal women a ROMA value equal to or greater than 2.99 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. 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; pp 203-228.e1-6

2. 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) and Time(s) Performed

Monday through Friday; 6 a.m.-12 a.m.

Saturday; 6 a.m.-6 p.m.

Analytic Time

1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been cleared or approved by the U.S. 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 In Process

 

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 Form (T729) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/oncology-request-form.pdf)