HE4 enzyme immunoassay regulatory update

FDA granted 510(k) clearance for Fujirebio's HE4 enzyme immunoassay (EIA) to be used in combination with CA125 blood test results and the Risk of Ovarian Malignancy Algorithm (ROMA) to aid in assessing the risk of finding malignant epithelial ovarian cancer on surgery in women over 18 years of age presenting with a pelvic mass for whom surgery is planned and who have not yet been referred to an oncologist. ...