The OVA1® Test is an aid to further assess the likelihood that malignancy is present when the physician's independent clinical and radiological evaluation does not indicate malignancy. The OVA1® Test is a qualitative serum test that combines the results of five immunoassays into a single numerical result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The test is not intended as a screening or stand-alone diagnostic assay, or for patients with a diagnosis of malignancy within the last 5 years, or to determine whether a patient should proceed to surgery. Samples that contain rheumatoid factor ?250 IU/mL cannot be used in the OVA1® Test. Triglyceride levels above 4.5 g/L may interfere with the assay and should not be used in the OVA1® Test.