The US Food and Drug Administration (FDA) Recommends Against the Use of Screening Tests for Ovarian Cancer

The FDA has issued a safety communication alerting women of the risks of ovarian cancer screening tests.

The FDA communication issued on September 7th, alerts women of the risks of ovarian cancer screening tests on the market due to their high number of inaccurate results, and stated “FDA is concerned that women and their physicians may be misled by such claims and rely on inaccurate results to make treatment decisions." The warning recommends that women should be aware that there is currently no safe and effective ovarian cancer screening test and to talk to their doctor about ways to reduce their risk of developing ovarian cancer. 

In response, Larry C. Kilgore, MD Director of the OB/GYN Division of Gynecologic Oncology and a Gynecologic Oncologist at The University of Tennessee Medical Center notes, “This is an excellent warning from the FDA and supports what we have known and said for many years. There is no reliable test to rule out or confirm early ovarian cancer. These tests should be used for patients at notable increased risk for ovarian cancer, and not for the low-risk patient who has no more than a 1.5 percent lifetime risk of ovarian cancer. In other words, a woman at normal risk has a 98.5 percent chance she will never have ovarian cancer."

 Patients at increased risk from family history or genetic mutations like BRCA or Lynch syndrome should be under increased surveillance not screening. Some patients in those situations may benefit from risk-reducing surgery to prevent ovarian cancer.

 In the United States this year, 22,280 new cases of ovarian cancer are expected to be diagnosed. To view the FDA safety communication, visit their website. For more information about the Gynecologic Oncology Program at the Cancer Institute call (865) 305-5622.