Fujirebio Diagnostics and Roche Diagnostics Sign Agreement for New Ovarian C... ( Fujirebio Diagnostics' HE4 Test will ...)

Fujirebio Diagnostics and Roche Diagnostics Sign Agreement for New Ovarian Cancer Test

Date:12/16/2008

Fujirebio Diagnostics' HE4 Test will be Available Through Roche Diagnostics' Automated Immunoassay Analyzers

MALVERN, Pa. and Basel, SwitzerlandDec. 16 /PRNewswire/ -- Fujirebio Diagnostics, Inc. and Roche Diagnostics announced today a worldwide license and supply agreement for the 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 CA125 alone. 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 conditions. Three quarters of ovarian cancer cases are diagnosed at an advanced stage, when it is more difficult to treat. More than 90 percent of patients who are diagnosed early (Stage I-II) will live past five years but only 20 percent of cases are diagnosed in the early stages.

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