Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Warns Against Ovarian Cancer Screening Tests

FDA news release; 2016 Sep 7

The FDA issued a safety communication alerting women to the risks associated with the use of tests being marketed as ovarian cancer screening tests. The concern is over potentially delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer. Based on the FDA’s review of clinical data from ovarian cancer screening trials and recommendations from healthcare professional societies and the US Preventive Services Task Force, available data do not demonstrate that currently available ovarian cancer screening tests are accurate and reliable in screening asymptomatic women for early ovarian cancer. Therefore, the FDA physician recommendations include:

  • Do not recommend or use tests that claim to screen for ovarian cancer in the general population of women. Be aware that testing higher risk asymptomatic patients for ovarian cancer has no proven benefit and is not a substitute for preventive actions that may reduce their risk.
  • Consider referring women at high risk of developing ovarian cancer, including those with BRCA mutations, to a genetic counselor or gynecologic oncologist, or other appropriate health care provider for more specialized care.


US Food and Drug Administration. Ovarian cancer screening tests: Safety communication—FDA recommends against use. FDA Web site. Accessed September 8, 2016.