About ROMA™

The Risk of Ovarian Malignancy Algorithm (ROMA) is used to combine the test results of CA125 and HE4. ROMA is used to stratify women into likelihood groups for finding ovarian malignancy on surgery.

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CA125 + HE4 =
Likelihood Stratification

Each year, an estimated 22,000 women in the United States will be diagnosed with ovarian cancer.1

The path to more optimal patient outcomes begins with the new CA125 + HE4 stratification tool. The CA125 + HE4 test combination from Fujirebio Diagnostics, Inc., helps connect ovarian cancer patients with the right doctor for the most optimal outcome. Explore more about ovarian cancer, the new CA125 + HE4 test, and how this test will help the steer patients down the right treatment path.

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Healthcare Professionals

Approximately 1 in 5 women
will develop a pelvic mass
in their lifetime.2 Learn
more about CA125 + HE4,
a new stratification
tool that can help
determine the most
appropriate course
of care.

Learn more »

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Patients & Caregivers

If you or someone you know has been diagnosed with ovarian cancer, or
are at a high-risk for
ovarian cancer, the
right treatment path
can lead to more
positive results.

Learn more >>

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.


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.

Click here for the full ROMA package insert.