No marketed screening test has been clinically proven to accurately diagnose ovarian cancer, according to a MedWatch announcement from the Food and Drug Administration.
Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results,” FDA officials said in a statement .
Officials with the American Congress of Obstetricians and Gynecologists echoed the FDA’s concern, pointing out that several ovarian cancer screening tests, including the CA-125 test and the Risk of Ovarian Cancer Algorithm test , are currently available and claim to detect ovarian cancer before symptoms occur. These claims are “not based on data,” ACOG president Thomas Gellhaus, MD , said in a statement .
The FDA and ACOG both expressed concern that the use of these tests could delay treatment for asymptomatic women with early-stage ovarian cancer and also may result in unnecessary medical procedures for women who receive positive test results even though no cancer is present.
“Using unproven ovarian cancer screening tests also may be harmful for women with increased risk for developing ovarian cancer,” the FDA wrote and added that “women at high risk for developing ovarian cancer should not use any currently offered test that claims to screen for ovarian cancer.”
Instead, women at high risk of developing ovarian cancer, including those with BRCA mutations, should be referred to a genetic counselor, gynecologic oncologist, or other appropriate health care provider for more specialized care, the FDA recommended. “Currently, it appears that the best way to detect ovarian cancer is for both the patient and her clinician to have a high index of suspicion of the diagnosis in symptomatic women. Persistent and progressive symptoms, such as an increase in bloating, pelvic or abdominal pain, or difficulty eating or feeling full quickly, should be evaluated,” Dr. Gellhaus added.
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