Patients and Caregivers

Early Detection and Risk Stratification

Take the right treatment path.

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about ROMA™.

Because the symptoms in the early stages of ovarian cancer are vague and tend to go unrecognized, diagnosis of the disease in the early stages—when it is most curable—is difficult. Although there is currently not a screening test available for ovarian cancer, a recent breakthrough has led to the discovery of a new way to help better predict the risk of malignancy.

For more than 20 years, the CA125™ test has been the gold-standard test used by doctors to monitor patients with any symptoms or risk factors of ovarian cancer. CA125 is a protein that is more prevalent in ovarian cancer cells. However, even though its level is elevated in about 80% of women with ovarian cancer, not all elevations of CA 125 indicate a malignancy. This is because CA125 can also be elevated in non-cancerous conditions, such as menstruation, endometriosis, pregnancy, pelvic inflammatory disease, and benign ovarian cysts. Therefore, there has long been a need for a more specific and precise way to detect the presence of ovarian cancer.

ROMA™ (Risk of Ovarian Malignancy Algorithm)

It was discovered that women with a pelvic mass who had elevated levels of a substance called Human Epididymis Protein 4 (HE4) in their blood were more likely to have ovarian cancer, and that this substance has a complementary relationship to CA125. By using both levels of CA125 and HE4 together, the accuracy in predicting the presence of ovarian cancer increased significantly.7

A follow-up study demonstrated the ability of the dual marker combination of HE4 + CA125 and the Risk of Ovarian Malignancy Algorithm (ROMA™) to classify women into high and low likelihood groups. This is an important and exciting new development in ovarian cancer research because it can help direct patients down the right treatment path.8

Please read the ROMA package insert for complete instructions on how to use ROMA to calculate the precise likelihood result.

Learn more about ROMA and HE4.