Women with elevated levels of a substance called HE4 in their
blood may be more likely to have ovarian cancer, according to results
of a prospective study recently published on-line in the journal of
Gynecologic Oncology. The findings offer a positive step forward in
the quest for a test for early detection of the disease dubbed the
"silent killer" for which there is no adequate screening test.
"Ovarian cancer is often difficult to diagnose because symptoms
are often recognized in the late stages of the disease when ovarian
cancer is fundamentally incurable," said Lead Researcher Dr. Richard
Moore, assistant professor in the Program for Women´s Oncology at
Women and Infants´ Hospital / Brown University. "Our research was
directed at identifying those unique characteristics or ´biomarkers´
of the disease that might one day help us detect this disease
earlier."
Currently, the gold standard for monitoring ovarian cancer is a
test that measures for elevated levels of the CA-125 substance in the
blood. The test can be limited in detecting all types of ovarian
cancer, prompting researchers to seek out additional biomarkers that
offer higher sensitivity and can be indicative of the disease to
complement CA-125.
In this study, Moore´s team evaluated nine potential biomarkers in
259 patients with pelvic mass. Researchers measured levels of each
biomarker within the women´s blood and then compared the results with
biopsies of their tumors. With 72.9 percent sensitivity and 95 percent
specificity, HE4 was the most effective biomarker for detecting
ovarian cancer. When CA-125 was added, the result was an even more
powerful combination of tests with sensitivity for detecting the
disease increased to 76.4 percent.
"Our results show testing women suspected of ovarian cancer for
both CA-125 and HE4 could possibly lead to a screening and diagnostic
tool," adds Moore. "This is exciting news, particularly for women in
the earliest stages of the disease when it is most treatable."
Moore´s study noted HE4 as the best single marker for Stage I
disease. Seventy to 75 percent of ovarian cancers are diagnosed at a
late stage when the five-year overall survival rate may only reach up
to 50%. However, in women diagnosed with Stage I disease, the
probability of a cure approaches 90-95 percent.
"This is an encouraging development not only for ovarian cancer
patients, but for all women with ovarian cysts as it can be
challenging to distinguish malignant tumors from benign ones with
current methods," said Dr. Olle Nilsson, vice president and chief
scientific officer of Fujirebio Diagnostics, the developers of the
CA-125 test. "A combination of tests could help clinicians better
define ovarian cysts so they can determine the most appropriate
treatment regimen for their patients."
Fujirebio Diagnostics has developed a manual test for HE4 and will
be developing automated formats of the test for Fujirebio instruments,
as well as, the Abbott Architect. The company plans to submit to the
U.S. Food and Drug Administration (FDA) for regulatory clearance of
the HE4 test later this year.
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.
