Diagnostics Oncology

 News Release - February 11, 2009

Biomarker Combination and Risk of Ovarian Malignancy Algorithm (Roma(TM)) Demonstrates Accuracy in Detecting Ovarian Cancer

Data Presented at the Society of Gynecologic Oncologists' 40th Annual Meeting on Women's Cancer Proves Superiority of HE4, CA125 and ROMA(TM) Over Existing Tools

MALVERN, Pa., Feb. 11 -- (Healthcare Sales & Marketing Network) -- New data presented on Saturday during the plenary session at the Society of Gynecologic Oncologists' 40th Annual Meeting on Women's Cancer demonstrated the accuracy of the HE4 test - in combination with CA125 blood test results and the Risk of Ovarian Malignancy Algorithm (ROMA(TM)) - in assessing the risk of ovarian cancer in women who will undergo surgery to remove a pelvic mass compared to the Risk of Malignancy Index (RMI). The data show that ROMA achieved greater sensitivity in distinguishing a benign mass from epithelial ovarian cancer (EOC) in premenopausal and postmenopausal women, and more accurately assigned patients with EOC to a high-risk group compared with RMI.

These results have important implications for the more than 280,000 American women who will be diagnosed with a pelvic mass over the course of a year. By combining the biomarkers HE4 and CA125 along with ROMA, the Fujirebio Diagnostics test appears to be more sensitive than the traditional RMI, which utilizes CA125 and imaging as well as menopausal status to evaluate the risk of ovarian cancer. CA125 is the current gold standard for monitoring patients diagnosed with ovarian cancer, but is less sensitive when used as a risk stratification tool, especially in premenopausal women, as elevated CA125 blood levels can result from non-cancerous conditions.

"These data confirm the utility of HE4 in the assessment of women with an ovarian cyst or pelvic mass, and can provide physicians with an accurate, objective tool to classify patients into high- and low-risk groups before surgery," said Richard Moore, MD, Assistant Professor of Obstetrics and Gynecology at Women and Infants Hospital and the Alpert Medical School at Brown University in Providence, RI. "By using a test with greater accuracy that is not reliant on subjective imaging, physicians can now identify those patients that are at a high risk for having a malignancy, potentially improving clinical outcomes for these women."

Dr. Moore presented data from a prospective, double-blind, multicenter trial of 457 evaluable women diagnosed with a pelvic mass. Blood samples were obtained from study participants to measure for levels of HE4 and CA125. Two separate algorithms for premenopausal (n=212) and postmenopausal (n=245) 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 EOC, surgical staging was required by protocol. All tissue specimens were examined to verify the diagnoses made by study site pathologists.

There were 123 patients determined to have an invasive EOC and 22 patients had a low malignant potential or borderline tumor. The remainder had various benign tumors. ROMA stratified 94.3% of the women with an invasive EOC correctly into a high-risk group.

Additionally, ROMA demonstrated greater accuracy in detecting ovarian cancer across all stages of disease, including early stage disease where 85.3% of the invasive EOCs were correctly identified.

"Currently, only 20% of women with ovarian cancer are diagnosed in the early stages, when the five-year life expectancy exceeds 90%," commented Dr. Moore, who is also the Director of Medical Education for the Program in Women's Oncology and a gynecologic oncologist at Women & Infants' Hospital in Providence, RI.

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 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.

Source: Fujirebio Diagnostics

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