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Biomarker Combination and Risk of Ovarian Malignancy Algorithm (Roma(TM)) Demonstrates Accuracy in Detecting Ovarian Cancer
Date:2/11/2009

he 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 United States 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 of ovarian cancer 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.

About Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. Fujirebio Diagnostics is one of the group companies of Miraca Holdings, Inc., in Japan, set up in July 2005 to combine Fujirebio Inc., the leading in-vitro diagnostics company, and SRL, Inc., the top provider of clinical laboratory testing services in Japan. Fujirebio Diagnostics has a worldwide distribution network which enables physicians and patients to access its diagnostic products. For more information about Fujirebio Diagnostics, please call

610-240-3800 or visit www.fdi.com.


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SOURCE Fujirebio Diagnostics, Inc.
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