LabCorp Offers New Test to Assess Ovarian Mass Malignancy
20 Jan 2012
Laboratory Corporation of America® Holdings has announced that its risk stratification tool for assessing ovarian masses has received clearance from the U.S. Food and Drug Administration. The Risk of Ovarian Malignancy Algorithm (ROMA), assesses whether an ovarian mass is at high or low likelihood of being malignant.
Approximately 300,000 women present with a pelvic mass every year. The symptoms related to the presence of these masses, is often vague and unspecific; and there is a need for an accurate and specific risk stratification tool to assess malignancy in these women to help ensure they receive the best possible treatment.
The primary goal of diagnostic evaluation of an adnexal mass is to determine whether it is benign or malignant. ROMA® combines the results for Fujjrebio HE4, Abbott’s ARCHITECT® CA 125 II, and menopausal status into a numerical score. This, along with clinical and radiological evaluation, can aid in assessing whether a woman over the age of 18 who presents with an ovarian mass, and for whom surgery is planned is at high or low likelihood of finding malignancy on surgery.
ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay and incorrect use of ROMA carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.