Malignant Tumor or Benign Cyst?: Researcher from Women & Infants´/Alpert Medical School Says Combination Tests Could Identify Women´s Ovarian Cancer Risk for More Accurate Diagnosis, Treatment

The results of a study presented today at the Society of
Gynecologic Oncology´s 39th Annual Meeting on Women´s 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 woman´s 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 Women´s 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 woman´s 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 women´s 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 women´s 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.

About Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics, Inc. is a premier diagnostics company and
the industry leader in 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.

About Women & Infants Hospital

Women & Infants Hospital of Rhode Island, a Care New England
hospital, is one of the nation´s leading specialty hospitals for women
and newborns. The primary teaching affiliate of The Warren Alpert
Medical School of Brown University for obstetrics, gynecology and
newborn pediatrics, Women & Infants is the ninth largest obstetrical
service in the country with more than 9,000 deliveries per year. In
2003, Brown University and Women & Infants were named a National
Center of Excellence in Women´s Health by the U.S. Department of
Health and Human Services. Women & Infants has been named one of the
best hospitals in gynecology in the 2000, 2001 and 2004 editions of
America´s Best Hospitals in U.S. News & World Report. For information
about Women & Infants, log on to www.womenandinfants.org.