Stop Using Ovarian Cancer Screening Tests, FDA Says

The FDA is alerting women and their health care professionals about risks associated with the use of ovarian cancer screening tests.

The FDA is alerting women and their health care professionals about risks associated with the use of ovarian cancer screening tests.

Currently, no tests are sensitive enough to screen for and detect ovarian cancer without a high number of inaccurate results. Nevertheless, many companies market screening tests that claim they can do so.

For instance, Abcodia Inc recently began marketing the Risk of Ovarian Cancer Algorithm (ROCA) test in the United States, claiming that it can screen for and detect ovarian cancer before symptoms appear and increase the chance for survival. However, available clinical data from ovarian cancer screening trials do not support Abcodia’s claims, or similar claims from other companies.

The FDA is concerned that women and their health care professionals may be misled by these claims and rely on inaccurate results to make treatment decisions. For example, some women may receive false-positive test results and undergo additional medical tests and/or unnecessary surgery that may cause complications. Others may receive false-negative results, which may lead them to delay or not seek surgery or other ovarian cancer treatments.

Using unproven ovarian cancer screening tests may also be harmful for women with increased risk for developing ovarian cancer because they may not take appropriate actions to reduce their future risk if they rely on a result that shows no cancer is currently present. Yet, this group of women is still at high risk of developing ovarian cancer later based on their gene mutation and/or family history.

For all of the above reasons, the FDA is recommending against using currently offered tests to screen for ovarian cancer.

At-risk women and their health care professionals should be aware that there is no safe or effective screening test for ovarian cancer. Women who have reached menopause, women who have a family history of ovarian cancer, and women with the BRCA1 or BRCA2 genetic mutations have the highest risk for developing ovarian cancer and should consult their health care professionals about ways to reduce their risk.

Pharmacists should not recommend or use tests that claim to screen for ovarian cancer in the general population of women. Also, 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 professional for more specialized care.