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news.Fujirebio Diagnostics, a cancer diagnostics company, and Abbott, a broad-based healthcare company have signed a licensing agreement to develop a new ovarian cancer test for use on Abbott's automated Architect diagnostic analyzers.
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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.
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) are pending clearance by the FDA for use in women who present with a pelvic mass.
Olle Nilsson, vice president and chief scientific officer of Fujirebio Diagnostics, said: 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.