Ovarian Malignancy Risk (ROMA®)

Serum

1.75 mL

1 mL (Note: This volume does not allow for repeat testing.)

Red-top tube or gel-barrier tube

The ROMA™ (Risk of Ovarian Malignancy Algorithm) calculation combines the results of the Roche Elecsys HE4 assay, Elecsys CA 125 II assay and menopausal status into a numerical score (Roche). The ROMA value 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 Calculation 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 values 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.

The Risk of Ovarian Malignancy Algorithm (ROMA) uses the combination of Elecsys HE4 and Elecsys CA 125 II assay values of a woman. The premenopausal or postmenopausal status must be based on ovarian function determined with information available from clinical evaluation and medical history.

• ROMA cannot be used as absolute evidence for the presence or absence of malignant disease.

• ROMA should not be used as a cancer screening test.

• ROMA has only been evaluated in women who will undergo a surgical intervention and is only intended for this population.

• ROMA should not be used without an independent clinical 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 oncology referral.

• ROMA has not been validated for the following groups: women previously treated for malignancy, women currently being treated with chemotherapy, pregnant women and women <18 years of age.

Elecsys HE4 results should not be used interchangeably with other manufacturers' methods for HE4 determinations in the ROMA calculation. Use only the Elecsys HE4 assay obtained from Roche.

Elecsys CA 125 II results should not be used interchangeably with other manufacturers' methods for CA 125 determinations in the ROMA calculation. Use only with the Elecsys CA 125 II assay obtained from Roche.

Values obtained from nondesignated methods or instrument platforms may produce incorrect ROMA results.

Antireagent antibodies (human antimouse antibody (HAMA) or heterophilic antibodies) in the patient sample may occasionally interfere with the assay, even though specific blocking agents are included in the buffers. Specimens containing levels of rheumatoid factor (RF) above 250 IU/mL may interfere with the ROMA result.

Electrochemiluminescence Immunoassay (ECLIA)

Ovarian cancer is the fourth most common cause of cancer- related death in women worldwide. In 2014, in the United States, 21,290 women were diagnosed with ovarian cancer and 14,180 died of it.¹ The symptoms of ovarian cancer are related to the presence of adnexal masses and are often vague and unspecific. The primary goal of diagnostic evaluation of an adnexal mass is to determine whether it is benign or malignant. It is estimated that 5% to 10% of women in the United States will undergo a surgical procedure for a suspected ovarian neoplasm during their lifetime, and 13% to 21% of these women will be found to have an ovarian malignancy.² The American College of Obstetricians and Gynecologists Practice Bulletin 174 published in 2016 states that consultation with or referral to a gynecologic oncologist is recommended for women (both premenopausal or postmenopausal) with an adnexal mass who have an elevated score on a formal risk assessment tests such as the ROMA.³ Since the majority of adnexal masses are benign, it is important to determine preoperatively whether a patient is at high likelihood for ovarian malignancy, in order to ensure proper management.

The ROMA value is used to stratify women into likelihood groups for finding cancer on surgery. To improve the management of patients presenting with adnexal mass, the results of the ROMA may be used in conjunction with Initial Cancer Risk Assessment (ICRA) in assessing the likelihood of finding malignancy on surgery in premenopausal and postmenopausal women presenting with an adnexal mass. Several studies looked at the sensitivity of the ROMA at predefined specificity for identifying ovarian cancer and found that the use of ROMA increases sensitivity compared with CA 125 or HE4 alone.^4-7 Moore et al. did a prospective, multi-center trial evaluating women with a pelvic mass who had an initial clinical risk assessment (ICRA) performed by a generalist. Adjunctive use of ROMA with ICRA improved the stratification of these women into low and high risk groups for ovarian cancer. The combination was particularly effective in ruling out malignant disease.⁸ In order to provide a specificity level of 75%, a cut- off point of greater than or equal to 1.14 was used for premenopausal and greater than of equeal to 2.99 was used for postmenopausal women who present with an ovarian adnexal mass.⁹ Women with ROMA results that are equal to or above these cut-off points are at high likelihood of finding malignancy on surgery.

Use of ROMA for stratification into low and high likelihood groups for finding malignancy on surgery

Using preoperatively collected serum samples, ROMA value were determined and the patients were stratified into a low or high likelihood group for finding malignancy on surgery.⁹ Samples were tested at three US testing sites. The following cut-off points were used in order to provide a specificity level of 75%:

Premenopausal women:

• ROMA score ≥1.14: high likelihood of finding malignancy

• ROMA score <1.14: low likelihood of finding malignancy

Postmenopausal women:

• ROMA score ≥2.99: high likelihood of finding malignancy

• ROMA score <2.99: low likelihood of finding malignancy

The reported results include both the likelihoods and associated ROMA scores for premenopausal and postmenopausal women on a scale of 0-10.