First to offer breakthrough ovarian cancer tests.
Ovarian cancer is the leading cause of death from gynecologic cancers in the U.S. and the fifth-leading cause of cancer deaths in women. Ovarian masses affect approximately one million women and lead to as many 300,000 ovarian mass surgeries in the U.S. each year. Quest Diagnostics is the only national lab to offer FDA-cleared OVA1™ test. 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 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 test is not intended as a screening or stand-alone diagnostic assay.
PRECAUTION: The OVA1™ Test should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1™ Test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.
A negative OVA1™ Test result, in the setting of a positive pre-surgical assessment, should not preclude oncology referral. The OVA1™ Test is not indicated for patients with a diagnosis of malignancy within the last 5 years.