FDA has recently issued an alert about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The agency is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk of developing ovarian cancer.

Despite extensive research and published studies, says the agency, 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. Nevertheless, over the years numerous companies have marketed tests that claim to screen for and detect ovarian cancer. FDA is concerned that women and their physicians may be misled by such claims, and may rely on inaccurate results to make treatment decisions.

Based on FDA’s review of available 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. For example, women who receive false-positive test results may undergo additional medical tests and unnecessary surgery, and may experience complications related to both. Or, false-negative test results may lead women to delay or not seek surgery or other treatments for ovarian cancer.

Using unproven ovarian cancer screening tests may also be harmful for women with increased risk of developing ovarian cancer. FDA cautions that such women and their doctors may not take appropriate actions to reduce their future risk if they rely on a result that shows no cancer currently present. Yet, based on their gene mutation or family history, this group of women is still considered to be at high risk for developing ovarian cancer. FDA believes that women at high risk for developing ovarian cancer should not use any currently offered test that claims to screen for ovarian cancer.

Further, based on currently available information, FDA recommends against using any of the currently offered tests to screen for ovarian cancer. For women, including those at increased risk of developing ovarian cancer, FDA offered the following recommendations:

  • Be aware that there is currently no safe and effective test for ovarian cancer screening.
  • Do not rely on ovarian cancer screening test results to make health or treatment decisions.
  • Women—and especially those with a family history of ovarian cancer, or those with BRCA1 or BRCA2 gene mutations—should talk to their doctors about ways to reduce the risk of developing ovarian cancer.

For physicians, FDA issued the following recommendations:

  • 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 healthcare provider, for more specialized care.

In the United States, ovarian cancer is the fifth leading cause of cancer-related death among women. The National Cancer Institute estimates that in 2016, more than 22,000 women will be diagnosed with ovarian cancer. Women who have reached menopause, women who have a family history of ovarian cancer, and women with the BRCA1 or BRCA2 gene mutations have the highest risk of developing ovarian cancer.

For more information, visit FDA.