European women facing "the silent killer" now have access to a
breakthrough test to identify their risk of ovarian cancer. Fujirebio
Diagnostics, the industry leader in biomarker assays, announces that
its HE4 test is now CE marked, a mandatory conformity mark on many
products placed on the single market in the European Economic Area
(EEA). Now available for sale throughout the European Union, the
simple blood test measures for a substance known as HE4, which many
studies have shown can be elevated in epithelial ovarian cancers. The
test is intended to be used in conjunction with the CanAg CA 125 EIA
or the Abbott ARCHITECT CA 125 II as an aid in estimating risk of
epithelial ovarian cancer in women presenting with a pelvic mass prior
to surgery.
For many years CA 125 has been the gold standard for monitoring
ovarian cancer; however, this test is limited in its sensitivity and
specificity as well as its ability to detect all types of ovarian
cancer, prompting researchers to seek out additional indicators or
"biomarkers" to complement CA 125 that offer higher sensitivity and
can be indicative of the disease.
"The new HE4 test is a major step in the fight against ovarian
cancer worldwide," said Dr. Olle Nilsson, vice president and chief
scientific officer of Fujirebio Diagnostics. "The same data used to
support the CE mark certification has been submitted to the U.S. Food
and Drug Administration (FDA) and we hope to see availability of the
test in the United States during 2008."
With the HE4 test, risk for epithelial ovarian cancer is
determined by using a mathematical algorithm that combines the HE4 and
CA 125 values. The test is also intended to be used as an aid in
monitoring response to therapy for patients with invasive epithelial
ovarian cancer.
Recently, the results of a study which looked at the ability of
various combinations of seven different biomarkers all known to be
expressed in ovarian cancer were published. The paper, which was
published in February 2008 in the journal Gynecologic Oncology, showed
that as a single biomarker, HE4 had the highest sensitivity for
detecting ovarian cancer, especially Stage I disease, and that when CA
125 and HE4 are combined they are a more accurate predictor of cancer
than either alone. These findings, combined with the new CE mark,
offer a positive step in the race for earlier detection and treatment.
"This powerful combination increases the sensitivity for detecting
a disease that is often difficult to diagnose because symptoms can be
confusing for patients to recognize," said Lead Researcher Dr. Richard
Moore, assistant professor of the Program for Women´s Oncology at
Women and Infants´ Hospital in Providence, Rhode Island, USA. "Our
research offers hope for a more effective way to manage and treat
ovarian cancer as well as a possible screening tool for women in the
earliest stages of the disease when it is most treatable."
This is the first commercially available test which when used in
combination with another test and a mathematical algorithm can
estimate the risk of finding ovarian cancer upon surgery in women who
present to their physician with a pelvic mass.
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 awaiting clearance by the FDA and is not available for
sale in the United States.
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.
