Roche licenses Fujirebio's ovarian cancer test
9 January 2009
Fujirebio Diagnostics, Inc. has granted Roche Diagnostics a worldwide
license and supply agreement for its HE4 ovarian cancer test. Under the
agreement, Roche will develop an assay kit utilizing Fujirebio
Diagnostics' HE4 test on its automated immunoassay analyzers.
The HE4 test was developed by Fujirebio Diagnostics to be used in
conjunction with the company's existing CA125 biomarker, the current
gold standard for monitoring ovarian cancer. This combination of
biomarkers, as published clinical data shows, provides clinicians with a
diagnostic tool that can provide higher sensitivity and specificity than
Improved sensitivity and specificity should allow clinicians to
distinguish between benign and malignant pelvic masses more accurately,
helping to ensure that patients receive appropriate therapy earlier.
"This novel biomarker HE4 will allow our longstanding partner Roche
Diagnostics to provide clinicians worldwide with a much needed tool to
better define a pelvic mass, enabling women at higher risk for cancer to
see the right physician earlier," said Paul Touhey, President and Chief
Executive Officer, Fujirebio Diagnostics.
Ovarian cancer is often difficult to diagnose because its symptoms —
bloating, pelvic or abdominal pain, difficulty eating or feeling full
quickly, urgent or frequent urination, gastrointestinal upset and
unexplained fatigue — are easily confused with other non-cancerous
Three quarters of ovarian cancer cases are diagnosed at an advanced
stage, when it is more difficult to treat. More than 90% of patients who
are diagnosed early (Stage I-II) will live past five years but only 20|%
of cases are diagnosed in the early stages.
HE4 in a manual format is currently FDA-cleared for monitoring
recurrent or progressive disease in patients with epithelial ovarian
cancer (EOC), and CE-marked in Europe as an aid in estimating the risk
of EOC in premenopausal or postmenopausal women presenting with pelvic
The HE4 manual test and corresponding Risk of Ovarian Malignancy
Algorithm (ROMA(TM)) are pending clearance by the United States FDA for
use in women who present with a pelvic mass.
"The HE4 test is another important pillar of our broad tumor marker
test menu. We expect that the HE4 test will contribute significantly to
our future growth in the area of oncology," said Dirk Ehlers, Head of
Roche Professional Diagnostics.
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