ROMA™ INTENDED USE
The Risk of Ovarian Malignancy Algorithm (ROMA™) is a qualitative serum test that combines the results of HE4 EIA, ARCHITECT CA 125 II™ and menopausal status into a numerical score.
ROMA is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. ROMA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay.
PRECAUTION: ROMA (HE4 EIA + ARCHITECT CA125 II) should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of ROMA (HE4 EIA + ARCHITECT CA125 II) carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.
ROMA, the combination of CA125 + HE4 tests, along with menopausal status, is used to help determine the likelihood of finding a malignancy on surgery in women who present with adnexal mass. Risk stratification helps ensure optimal patient care by promoting the triage of patients at high risk of ovarian malignancy to tertiary care centers with multidisciplinary teams that specialize in ovarian cancer.
In a recent study, ROMA was evaluated in 472 women with adnexal mass who were initially assessed by generalist Ob/Gyns and primary care physicians and subsequently underwent surgery. ROMA correctly identified 94% of women with an epithelial ovarian cancer as high risk. These patients can be referred to specialized gynecologic oncologists for optimal care. At the same time, 75% of patients with benign disease were correctly identified and could undergo treatment by their gynecologist in the community.2
In summary, the CA125 + HE4 combination accurately determines risk of malignancy:2
- Many markers have been studied, but the CA125 + HE4 combination has proven to be a more accurate predictor of malignant disease than either marker alone.1
- Patients classified as being at increased risk for ovarian cancer can be referred to a gynecologic oncologist (GYN/ONC) for optimal care.3,4
- In a prospective multi-center study, the combination assay yielded a sensitivity of 94%, with a fixed specificity of 75%.2
- Moore RG, Brown AK, Miller CM, et al. The use of multiple novel serum tumor markers for the detection of ovarian carcinoma in patients with a pelvic mass. Gynecol Oncol. 2008;108(2):402-408.
- Moore, R.G., et al., Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass. Obstet Gynecol, 2011. 118(2 Pt 1): p. 280-8.
- Guidelines for referral to a gynecologic oncologist: rationale and benefits. The Society of Gynecologic Oncologists. Gynecol Oncol. 2000;78(3 Pt 2):S1-S13.
- Giede, K.C., et al., Who should operate on patients with ovarian cancer? An evidence-based review. Gynecol Oncol, 2005. 99(2): p. 447-61.