The FDA recommends against using screening tests for ovarian cancer screening FDA Safety Communication

SUMMARY: The American Cancer Society estimates that about 22,440 women will be diagnosed with ovarian cancer in the United States for 2017 and about 14,080 will die of the disease. Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. 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. Over 75% of patients with ovarian cancer have advanced disease at the time of diagnosis. The FDA Safety Communication noted that despite extensive research and published studies 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.

The 2 tests used most often to screen for ovarian cancer are TransVaginal UltraSound (TVUS) and serum marker CA-125. TVUS is unable to differentiate benign from malignant ovarian mass. Serum marker CA-125 is usually associated with high-grade serous ovarian cancer, but is also expressed in normal tissues of the body such as the lungs and other reproductive organs. An increase in the serum marker CA-125 can be seen in non-malignant conditions such as endometriosis, peritonitis and in women with uterine fibroids. Even though serum marker CA-125 when elevated in patients, with an established diagnosis of ovarian cancer, is often used to follow the course of the disease, it has never been proven as an effective screening test for the early detection of ovarian cancer.

Nonetheless, numerous companies continue to claim that their commercially available diagnostic tests can effectively screen and detect ovarian cancer, with no data to support their claims. The FDA is concerned that women and their health care providers may rely on these inaccurate test results to make treatment decisions. Women with a false-positive result may undergo additional medical tests and/or unnecessary surgery, and may experience complications related to both. Conversely, women with a false-negative test may delay or not seek surgery or other treatment interventions for ovarian cancer. The later is particularly relevant for patients with BRCA mutations. Approximately 40% of BRCA1-mutation carriers and 18% of BRCA2-mutation carriers will develop ovarian cancer by age 70. It is recommended that patients who have BRCA1 mutations consider risk-reduction surgery (hysterectomy and bilateral bilateral salpingo-oophorectomy) by age 40 and those with BRCA2-mutations consider risk-reduction surgery no later than age 50.

Even though screenings for breast, colon and cervical cancers are successfully used for early detection and prevention of cancer-related deaths, a screening test for ovarian cancer with valid scientific data presently does not exist, and the FDA recommends against using currently offered tests to screen for ovarian cancer.


For women, including those at increased risk of developing ovarian cancer

• Be aware that there is currently no safe and effective ovarian cancer screening test

• Do not rely on ovarian cancer screening test results to make health or treatment decisions

• Talk to your doctor about ways to reduce your risk of developing ovarian cancer, especially if you have a family history of ovarian cancer, or have the BRCA1 or BRCA2 genetic mutations

For physicians

• 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

U.S. Food and Drug Administration: The FDA recommends against using screening tests for ovarian cancer screening: FDA Safety Communication. Issued September 7, 2016. Available at