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Fujirebio Diagnostics, Inc. and Abbott have entered into a license agreement to develop a new test for ovarian cancer using automated diagnostic analyzers ARCHITECT (R) from Abbott. Under the agreement, Fujirebio Diagnostics to develop and manufacture the Abbott biomarker HE4, a simple blood test can help the risk stratification of women at high risk for ovarian cancer, a disease difficult to detect in its early stages.

HE4 in a manual format is currently approved by the FDA to monitor the progressive or recurrent disease in patients with epithelial ovarian cancer (EOC) and CE marked in Europe to help estimate the risk of EOC in premenopausal and postmenopausal women who pelvic mass. The HE4 test manual and the Risk of Ovarian Malignancy Algorithm (ROMA (TM)) are pending for approval by the Food and Drug Administration U.S. (FDA) for use in women with a pelvic mass.