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.
Dr. Kevin Holcomb, M.D. presents Novel Cancer Biomarkers: Assessing the Pelvic Mass Patient with ROMA™ (presented on July 9, 2012)
Dr. Barbara Goff, M.D. presents Novel Cancer Biomarkers: Assessing the Pelvic Mass Patient with ROMA™ (presented on July 18, 2012)
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.
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.
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 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.
Click here for the full ROMA package insert.