Healthcare Professionals

Healthcare Professionals

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Take our quick poll about HE4 and ROMA™, then see how your results compare with others.


Ovarian cancer is not the silent killer it was once thought to be. Studies have shown that there are symptoms that appear in the early stages of the disease. Recognition of these symptoms in the early stages is critical. Currently, less than 20% of cases are diagnosed in the early stages, and the 5-year survival rate is 20% to 30% when diagnosed at stage III or IV, but when diagnosed in the early stages the probability of cure increases to 90% to 95%.5

A new biomarker, HE4, improved detection and specificity for detection of ovarian cancer over that of CA125 alone. HE4 was also found to increase the sensitivity of CA125 for the detection of ovarian cancer in patients presenting with a pelvic mass.

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.

Click here for the full ROMA package insert.

OBG Management LogoRead "In women who have a pelvic mass
Have you tried this new ovarian Ca biomarker?"

recently published in OBG Management.

Read more about this breakthrough novel serum biomarker.


Webinar: Dr. Kevin Holcomb

Dr. Kevin Holcomb, M.D.
Dr. Kevin Holcomb, M.D. presents Novel Cancer Biomarkers: Assessing the Pelvic Mass Patient with ROMATM (presented on July 9, 2012)

Webinar: Dr. Barbara Goff

Dr. Barbara Goff, M.D.
Dr. Barbara Goff, M.D. presents Novel Cancer Biomarkers: Assessing the Pelvic Mass Patient with ROMATM (presented on July 18, 2012)