FDA Product Code ONX: Ovarian Adnexal Mass Assessment Score Test System

An Ovarian/adnexal Mass Assessment Test Is A Devicem That Measures One Or More Proteins In Serum. It Yields A Single Result For The Likelihood That An Adnexal Pelvic Mass In A Woman, For Whom Surgery Is Planned, Is Malignant. The Test Isn For Adjunctive Use, In Teh Context Of A Negative Primary Clinical And Radiological Evaluation, To Augmrent The Identification Of Patienets Whose Gynecologic Surgery Requires Oncology Expertise And Resources.

Leading manufacturers include Fujirebio Diagnostics,Inc., Vermillion, Inc. and Roche Diagnostics.