New & Noteworthy

Fall 2012

Risk of Ovarian Malignancy Algorithm

Fujirebio US, Inc

Fujirebio Diagnostics has received 510(k) clearance from the FDA to market the HE4 Test in an algorithm called ROMA (Risk of Ovarian Malignancy Algorithm), which combines the HE4 EIA assay with the ARCHITECT CA 125 II and menopausal status into a numerical score. ROMA is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. PRECAUTION: ROMA (HE4 EIA + ARCHITECT CA 125 II) should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of ROMA carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

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