Expect Questions About the FDA Discouraging Use of Ovarian Cancer Screening Tests

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It is a very appropriate question for patients to ask about screening, but it is the job of the physician to communicate with them that there are not any good screening tests for ovarian cancer.
— Sanaz Memarzadeh, MD, PhD

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The release of a U.S. Food and Drug Administration (FDA) Safety Communication “alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests”1 and recommending against using these tests comes not as a result of startling new studies, but from an accumulation of extensive research and published studies. “However, over the years, numerous companies have marketed tests that claim to screen for and detect ovarian cancer,” the FDA Safety Communication noted. “The FDA is concerned that women and their physicians may be misled by such claims and rely on inaccurate results to make treatment decisions.”

Recommendations for Women

To counter misleading claims, the FDA recommends that women, including those at increased risk for ovarian cancer, take the following steps:

  • Be aware 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 the have the BRCA1 or BRCA2 genetic mutation.

Recommendations for Physicians

That advice to women to talk to their doctors, as well as national media coverage of the FDA recommendations, including the PBS NewsHour The Rundown,2 is likely to generate more questions to physicians about ovarian cancer screening.

“It is a very appropriate question for patients to ask about screening, but it is the job of the physician to communicate with them that there are not any good screening tests for ovarian cancer,” Sanaz Memarzadeh, MD, PhD, told The ASCO Post. Dr. Memarzadeh is Professor in the Department of Obstetrics and Gynecology at UCLA, a gynecologic cancer surgeon, and Director of the Gynecologic Oncology Discovery Laboratory (affiliated with the UCLA Jonsson Comprehensive Cancer Center).

In its Safety Communication, the FDA counseled physicians as follows:

  • 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.

Staying Alert to Potential Symptoms

Although the FDA recommendation applies only to screening for ovarian cancer among asymptomatic women, “it is really important for women to be aware of those symptoms that could be associated with it,” Dr. Memarzadeh said. “A lot of times we see patients who have had symptoms but didn’t think much of them or didn’t think to make the connection to ovarian cancer. Or physicians didn’t think to make the connection to ovarian cancer. So it is important to talk about those symptoms,” she indicated.

“The symptoms could be bloating, increased abdominal size, difficulty with eating, for example, getting full too quickly. Sometimes there may be changes in their bowel or bladder habits. Many of us may experience these kinds of symptoms one day and then feel better the next day, but if someone has these symptoms and they are not going away but are persistent, that person should talk to their doctor,” Dr. Memarzadeh advised. “At that point, it is very reasonable to consider doing a pelvic ultrasound to see what it found,” she added. To further explore, it is important to add ovarian cancer to the list in this differential diagnosis. ■

Disclosure: Dr. Memarzadeh reported no potential conflicts of interest.


1. 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 http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm519413.htm. Accessed September 23, 2016.

2. Kaplan S: FDA expresses concern over widely used ovarian cancer screening test. PBS NewsHour, The Rundown, September 9, 2016. Available at http://www.pbs.org/newshour/rundown/fda-expresses-concern-widely-used-ovarian-cancer-screening-test/. Accessed September 23, 2016.

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The FDA Urges Physicians and Patients to Forgo Ovarian Cancer Screening Tests

I strongly agree with the [FDA]. There are no effective ovarian cancer screening tests at this time, though an effective test is clearly needed.
— Sanaz Memarzadeh, MD, PhD

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In a Safety Communication directed at women and physicians, the U.S. Food...




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