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Malignant tumor or benign cyst?

The results of a study presented today at the Society of Gynecologic Oncologys 39th Annual Meeting on Womens Cancer offer a promising development on the path toward better management of ovarian cancer. Researchers say testing women suspected of having ovarian cancer for a combination of proteins, or biomarkers in the blood called HE4 and CA 125, could be the key to predicting a womans risk for the disease dubbed the silent killer. Currently there is no adequate diagnostic test for ovarian cancer.

Roughly 20 percent of women will be diagnosed with an ovarian cyst or tumor at some point in their life, and only a small percentage of these women will be diagnosed with ovarian cancer, said Lead Researcher Richard Moore, M.D., assistant professor at The Warren Alpert Medical School of Brown University and a gynecologic oncologist in the Program in Womens Oncology at Women & Infants Hospital of Rhode Island. The problem is that current methods for distinguishing benign ovarian tumors from malignant ones are limited and as a result, women must undergo surgery without an accurate assessment as to their risk for having ovarian cancer prior to their surgery.

Dr. Moore notes that fewer than half of all ovarian cancer patients have their initial surgery performed by a gynecologic oncologist or surgeon with specialized training in the management of ovarian cancer. Our research is aimed at identifying patients at high risk for harboring an ovarian cancer so that they receive the right care from the right physician.

Currently, CA 125 is the only blood test that can be used to help predict a womans risk for ovarian cancer and to help with the clinical management of the disease. However, CA 125 alone lacks the sensitivity required for the detection of ovarian cancer prompting researchers to look at the ability of combinations of biomarkers to predict the presence of ovarian cancer. Earlier this year, Dr. Moore published results of a pilot study in the journal of Gynecologic Oncology evaluating nine potential biomarkers and the ability of multiple marker combinations to predict the risk for ovarian cancer in women. His findings showed the combination of HE4 and CA 125 provided the highest level sensitivity and specificity out of all marker combinations for predicting the presence of ovarian cancer.

In a prospective, double-blinded, multicenter clinical trial, Dr. Moore and his team studied 496 women presenting with pelvic mass or ovarian cysts to determine if tests targeting multiple markers utilizing HE4 and CA 125 and a predictive algorithm could accurately assess the risk for epithelial ovarian cancer prior to surgery. Researchers measured levels of the biomarkers within the womens blood and then compared the results with biopsies of their tumors. The combination of biomarkers performed well in both pre- and post-menopausal women, accurately stratifying 95 percent of patients with epithelial cancer as high risk and 75 percent of benign cases as low risk.

Studies suggest women with ovarian cancer have better outcomes and increased survival when treated by surgeons trained in the management of ovarian cancer and at institutions specializing in the care of women with this disease, adds Dr. Moore. By using the combination of HE4 and CA 125 as a model to assess a womens risk for ovarian cancer, physicians can better triage patients for care and refer them to the appropriate specialist whether at a community hospital or large academic institution.

Together, HE4 and CA 125 offer a powerful combination that could dramatically change the way ovarian cancer is managed at all stages of care, said Dr. Olle Nilsson, vice president and chief scientific officer of Fujirebio Diagnostics, the developers of the CA 125 test. As research continues to progress, it is our hope that a test for HE4 and CA 125 could eventually lead to a plausible screening tool.

Fujirebio Diagnostics has developed a manual test for HE4 and will be developing automated formats of the test for Fujirebio instruments. The HE4 test is CE marked in Europe. The company has applied to the U.S. Food and Drug Administration (FDA) and hopes to see availability of the test in late 2008.


Contact: Stephanie Euler
908-276-4344 x213
Fujirebio Diagnostics

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