NORTH CHICAGO (dpa-AFX) - Laboratory Corporation of America Holdings (LH) Wednesday said the new FDA cleared risk stratification tool, Risk of Ovarian Malignancy Algorithm or ROMA is now available nationwide. ROMA combines the results for Fujirebio Diagnostics, Inc.'s HE4 test, Abbott's (ABT) ARCHITECT CA 125 II, and menopausal status into a numerical score. Along with clinical and radiological evaluation, the score can evaluate whether a woman over the age of 18 with an ovarian mass and for whom surgery is planned, is at high or low likelihood of finding malignancy on surgery. Approximately 300,000 women are diagnosed with pelvic mass every year with an overwhelming percentage being mild. The symptoms of ovarian cancer that are related to the presence of masses are often vague and unspecific. The primary goal of diagnostic evaluation of an adnexal mass is to determine whether it is mild or malignant.
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