FDA Clears Two Blood Tests to Predict Ovarian Cancer

Last week the U.S. Food and Drug Administration (FDA) cleared the use of blood tests for two proteins, HE4 and CA-125; biomarkers that together can be used to estimate risk for ovarian cancer in women who present with a pelvic mass. A recent study has shown that using HE4 and CA-125 data in conjunction with the Risk of Ovarian Malignancy Algorithm, or ROMA, determines ovarian cancer risk in both pre- and post-menopausal women with a higher degree of accuracy.

Ovarian cancer is difficult to diagnose, both because of the difficulty of differentiating between a benign pelvic mass and a malignancy and because symptoms are often confused for other conditions. For this reason, 75% of ovarian cancer cases are diagnosed at later stage.

A teal ribbon, which is an awareness ribbon for Ovarian cancer.

To date, CA-125 levels have been used to monitor patients previously diagnosed with ovarian cancer, however, the tests have proven incapable of identifying all types of ovarian cancer; likewise HE4 is often elevated in epithelial ovarian cancers, but has similar shortcomings.

A group led by Richard Moore, Director of the Center for Biomarkers and Emerging Technology in the Program in Women’s Oncology at Women & Infants Hospital of Rhode Island, reported the results of the study, which looked into the use of this combination of HE4/CA-125 and the ROMA algorithm, in the August 2011 issue of the journal Obstetrics & Gynecology (doi: 10.1097/AOG.0b013e318224fce2).

The study undertaken by Moore et al was a prospective, multicenter trial that accepted women who presented with an adnexal mass. Serum HE4 and CA-125 were determined and a ROMA score was calculated: two different algorithms were created for pre- and post-menopausal women, which allowed researchers to categorize women into high-risk or low-risk groups for malignancy. In total, 472 patients were included in the study; 383 were categorized as having benign disease while 89 had a malignancy. For the entire group of women, the Risk of Ovarian Malignancy Algorithm had a sensitivity of 93.8%, a specificity of 74.9%, and a negative predictive value of 99.0%.

This study, in conjunction with the FDA’s clearance of the HE4/CA-125 blood tests, should translate into a much greater percentage of ovarian cancers being picked up at earlier stage. Additionally, combining the use of the blood tests with the ROMA algorithm should enable physicians to differentiate benign disease from ovarian cancer with greater accuracy.