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FDA clears biomarker test for ovarian cancer
Date:9/6/2011

alignancy who should have their surgery performed by a gynecologic oncologist.

"Patients who have ovarian cancer have better outcomes when their surgery is performed by a gynecologic oncologist at centers experienced in the management of this disease," Dr. Moore said. "This combination test will change the way doctors diagnose and treat ovarian cancer."

Ovarian cancer is called a "silent killer" because it is difficult to diagnose with symptoms that are easily confused with other non-cancerous conditions. Three quarters of ovarian cancer cases are diagnosed at an advanced state, when the disease is more difficult to treat. Of patients who are diagnosed early (Stage I-II), more than 90 percent will live past five years. However, only one quarter of cases are diagnosed in the early stages.

"Any test that can help to identify women at high risk of ovarian cancer so that they can receive the right care by the right physician has real-world clinical impact today," said Cornelius "Skip" Granai, MD, director of the Program in Women's Oncology. "It is especially exciting that this was developed as a result of research spearheaded by one of our doctors. Dr. Moore has spent years probing answers for women with ovarian cancer and it is a medical breakthrough to be able to help detect ovarian cancer during its early stages."

Clearance of ROMA as a risk-stratification tool is based on results of a prospective, double-blind, multicenter trial involving 472 women with pelvic mass who were scheduled for surgical intervention. Blood samples were obtained from these women to measure for levels of HE4 and CA125. Two separate algorithms for premenopausal and postmenopausal women stratified patients into low- and high-risk groups. All patients then underwent surgical removal of the pelvic mass, and if a patient was diagnosed with an epithelial ovarian cancer, surgical staging was required by protocol. All tissue specimens were examined to verify the
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Contact: Susan McDonald
slmcdonald@womenandinfants.org
401-681-2816
Women & Infants Hospital
Source:Eurekalert

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