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Pivotal Data Published For First Biomarker Combination Test to Determine Risk of Ovarian Cancer in Women Who Present With Pelvic Mass
Date:1/26/2009

al referral patterns and improved outcomes," said Karen Orloff Kaplan, Sc.D., Chief Executive Officer of the Ovarian Cancer National Alliance.

About HE4

HE4 in a manual format is currently FDA cleared for monitoring recurrent or progressive disease in patients with EOC, and CE-marked in Europe as an aid in estimating the risk of EOC in premenopausal or postmenopausal women presenting with a pelvic mass. The test is currently available in the U.S. exclusively through Quest Diagnostics Incorporated (NYSE: DGX). The HE4 manual test and corresponding Risk of Ovarian Malignancy Algorithm (ROMA(TM)) are pending clearance by the FDA for use in women who present with a pelvic mass.

About Ovarian Cancer

Ovarian cancer is the leading cause of death from gynecologic cancers in the U.S. and the fifth-leading cause of cancer death in women. It accounts for 31% of cancers of the female genital organs. There are an estimated 22,000 new cases annually in the U.S. Women who are postmenopausal are at the greatest risk for ovarian cancer. In their lifetimes, 1 in 72 women will develop ovarian cancer.

Ovarian cancer is difficult to diagnose because its symptoms are easily confused with other non-cancerous conditions: bloating, pelvic or abdominal pain, difficulty eating or feeling full quickly, urgent or frequent urination, gastrointestinal upset and unexplained fatigue. Three quarters of cases of ovarian cancer are diagnosed at an advanced stage, when it is fundamentally incurable. Of patients who are diagnosed early (Stage I-II), more than 90 percent will live past five years. However, only 20 percent of cases are diagnosed in the early stages.

About Fujirebio Diagnostics

Fujirebio Diagnostics is the premier cancer diagnostics company and the industry leader in cancer b
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SOURCE Fujirebio Diagnostics
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