On September 7, 2016, the U.S. Food and Drug Administration (FDA) issued an alert for women about the risks involved with ovarian cancer screening tests. According to the FDA, no current screening test is sensitive enough to identify ovarian cancer without inaccurate results. As such, the FDA is concerned that patients and physicians might be misled by these results and make unnecessary treatment decisions.

Moreover, the FDA warned against the tests even for women who might be at an elevated risk for developing ovarian cancer. If patients rely on inaccurate tests, especially those showing no ovarian cancer, the FDA is concerned that patients and physicians may not take the appropriate preventive actions for the future. 

According to the FDA announcement, “Screenings for breast, colon, and cervical cancers are successfully used for early detection and prevention of cancer-related deaths. At this time, the FDA is not aware of any valid scientific data to support the use of any test, including using a test cleared or approved by FDA for other uses, as a screening tool for ovarian cancer.”

The FDA encouraged women to speak with their doctors about ways to reduce the risk of ovarian cancer. Physicians should consider referring high-risk women to a genetic counselor or oncologist for more specialized ovarian cancer care. If you have questions or comments, contact the Division of Industry and Consumer Education at dice@fda.hhs.gov.