The OVA1 test, which was cleared by the Food and Drug Administration (FDA) in 2009, measures the blood levels of five proteins in women with a known ovarian mass. These values have been reported to change when ovarian cancer is present, and the test may be useful in identifying women who should be referred to a gynecologic oncologist.
Recent data have suggested that the OVA1 test along with physician clinical assessment may improve detection rates of malignancies among women with pelvic masses planning surgery.1,2 Results from an OVA1 test should not be interpreted independently, nor be used in place of a physician’s clinical assessment.
Physicians are strongly encouraged to reference ACOG’s 2011 Committee Opinion “The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer” to determine an appropriate care plan for their patients. It is important to note that OVA1 has neither been evaluated for use as, nor cleared by, the FDA as a screening tool for ovarian cancer.
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[1] Bristow RE, Smith A, Zhang Z, Chan DW, Crutcher G, Fung ET, et al. Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay. Gynecol Oncol 2013;128: 252–259.
[2] Ueland FR, Desimone CP, Seamon LG, Miller RA, Goodrich S, Podzielinski I, et al. Effectiveness of a multivariate index assay in the preoperative assessment of ovarian tumors. Obstet Gynecol 2011;117:1289-1297.