The FDA has cleared a new test from Fujirebio Diagnostics (Malvern, Pennsylvania) that is expected to help physicians assess whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of malignancy. Fujirebio says its HE4 test was cleared for use in the Risk of Ovarian Malignancy Algorithm (ROMA). (Medical Device Daily)