FDA Issues Safety Alert Against Ovarian Cancer Screening Tests

FDA Issues Safety Alert Against Ovarian Cancer Screening Tests
The U.S. Food and Drug Administration (FDA) is alerting women and their clinicians about tests that are marketed to detect ovarian cancer. The FDA is particularly concerned that inaccurate results of these tests will delay the administration of preventive treatments for women at risk for developing ovarian cancer. "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," the FDA stated in a safety communication. Ovarian cancer is the fifth leading cause of cancer-related death among women and is estimated to affect 22,000 women this year alone. Women who reached menopause, have a history of ovarian cancer, or have mutations in the BRCA1 or BRCA2 genes have the highest risk for developing ovarian cancer. Identifying the disease in early stages is critical, as the five-year survival rates increase to 90 percent in those women. Many companies have developed tests that claim to screen for and detect ovarian cancer, but there is no available data showing that these tests are truly reliable and accurate in screening early ovarian cancer. Using these tests to guide treatment decisions comes with high risks. Patients who receive false-positive test results -- which suggest ovarian cancer even though the cancer is not there -- may undergo more tests and perhaps even unnecessary surgery, which comes with the risk of complications. Those who receive a false-negative, a test result that does not show ovarian cancer even though the cancer is present, may not seek surgery or other treatments. In addition, these tests may
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