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Fujirebio Diagnostics and Abbott Agree To Develop New Ovarian Cancer Test for Abbott's Architect(R) Analyzers
Date:1/27/2009

Test may help physicians identify effective treatment earlier

MALVERN, Pa. and Abbott Park, Ill., Jan. 27 /PRNewswire/ -- Fujirebio Diagnostics, Inc. and Abbott have signed a license agreement to develop a new ovarian cancer test for use on Abbott's automated ARCHITECT(R) diagnostic analyzers. Under the agreement, Fujirebio Diagnostics will develop and manufacture for Abbott the HE4 biomarker, a simple blood test that may help in the risk stratification of women at high risk for ovarian cancer, a difficult disease to detect in its early stage.

"While the medical industry has familiarized the public with warning signs and symptoms of ovarian cancer, the key to combating this lethal disease is better detection tools and technologies," said Olle Nilsson, Ph.D., vice president and chief scientific officer, Fujirebio Diagnostics. "The HE4 test, which is expected to be available in 2009, will allow Abbott, on the ARCHITECT system, to provide clinicians worldwide with a tool to help define a pelvic mass so that appropriate treatment can be best identified earlier and more effectively."

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 a pelvic mass. The HE4 manual test and corresponding Risk of Ovarian Malignancy Algorithm (ROMA(TM)) are pending clearance by the United States Food and Drug Administration (FDA) for use in women who present with a pelvic mass.

"More than 250,000 women present to their physician each year with a suspicious pelvic mass, yet there is still no reliable tool to differentiate malignant disease from other benign gynecologic conditions," said Robert Doss, Ph.D., divisional vice president, research and development, Abbott Diagnostics. "HE4 represents an impo
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SOURCE Fujirebio Diagnostics, Inc.
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