Clinical |

ACOG Statement on FDA Safety Communication on Ovarian Cancer Screening Tests

Washington, DC—Thomas Gellhaus, MD, President of the American College of Obstetricians and Gynecologists (ACOG), released the following statement on the release of the U.S. Food and Drug Administration’s (FDA) Safety Communication about ovarian cancer screening tests:

“As the nation’s leading group of physicians providing health care for women, ACOG understands the necessity of an effective screening test for ovarian cancer: it is the fifth leading cause of death by cancer in women. In 2013, 20,927 women in the United States were diagnosed with ovarian cancer, and 14,276 women in the United States died from ovarian cancer.


“Unfortunately, the existing evidence does not support any test to effectively screen for ovarian cancer. More research is still needed. As stated in ACOG’s Committee Opinion, “The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer,” at this time, there is no effective strategy for ovarian cancer screening. Available ovarian cancer screening tests, such as the Risk of Ovarian Cancer Algorithm (ROCA) test, are neither accurate nor reliable to screen asymptomatic women for early ovarian cancer. Currently, it appears that the best way to detect ovarian cancer is for both the patient and her clinician to have a high index of suspicion of the diagnosis in symptomatic women. Persistent and progressive symptoms such as an increase in bloating, pelvic or abdominal pain, or difficulty eating or feeling full quickly, should be evaluated.

“Obstetrician-gynecologists should be aware that tests currently marketed to screen women for ovarian cancer are not based on data. ACOG is in agreement with the FDA and recommends against using these offered tests to screen for ovarian cancer.”

For more information, please see ACOG’s Practice Advisory.

The American College of Obstetricians and Gynecologists (The College), a 501(c)(3) organization, is the nation’s leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of more than 57,000 members, The College strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women’s health care. The American Congress of Obstetricians and Gynecologists (ACOG), a 501(c)(6) organization, is its companion organization.