• Assess the likelihood that an ovarian mass is malignant in women whose pre-surgical assessment did not indicate malignancy

• Assess the need to refer the patient to a gynecologic oncologist for treatment

Although 22,280 women are expected to be diagnosed with ovarian cancer in 2012,¹ many more will undergo evaluation to determine whether their ovarian tumor is malignant. The American College of Obstetricians and Gynecologists (ACOG) and the Society of Gynecologic Oncologists (SGO) believe that pre-surgical evaluation should include menopausal status, physical examination, transvaginal ultrasonography, CA 125 concentration, and family history of breast or ovarian cancer in a first-degree relative.² These parameters can help the primary care physician or gynecologist determine the likelihood of cancer and whether or not to refer the patient to a gynecologic oncologist. Women with ovarian cancer who are treated by a gynecologic oncologist tend to have better outcomes relative to those treated by a non-gynecologic oncologist.^2,3

The Risk of Ovarian Malignancy Algorithm (ROMA) can be used as a supplement to the standard presurgical evaluation to further assess the likelihood of malignancy before surgery when the presurgical evaluation does not indicate malignancy. It combines the results of human epididymis protein 4 (HE4) enzyme immunometric assay (EIA), ARCHITECT CA 125 II™, and menopausal status to generate a single numerical score that correlates with the likelihood of malignancy being seen at surgery.

The ROMA test is intended for use in women who meet the following criteria:

• Are over 18 years of age

• Have an ovarian mass

• Surgery is planned

• Not yet referred to an oncologist

The ROMA test should not be used in women who have a rheumatoid factor concentration >250 IU/mL.