FDA Warns Against Using Ovarian Cancer Screening Tests

The above headline comes from a September 7, 2016, article published on the medical informational website Medscape. The article, as well as several others in the news, stem from an FDA report released on September 8, 2016, titled, “Ovarian Cancer Screening Tests: Safety Communication – FDA Recommends Against Use.”

The FDA warning notes that doctors should not recommend the screening tests to women due to the high likelihood that the test will yield inaccurate results and lead to unneeded treatments or the lack of preventative measures. In what was called a safety communication, the FDA stated, “Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for (the cancer) without a high number of inaccurate results.”

The FDA website provided background information on ovarian cancer by noting, “Ovarian cancer occurs when abnormal cells in or near the ovaries grow and form a malignant (cancerous) tumor. In the United States, ovarian cancer is the fifth leading cause of cancer-related death among women.”

In stating the findings for issuing this warning, the FDA explained, ” Based on the FDA’s review of available clinical data from ovarian cancer screening trials and recommendations from healthcare professional societies and the U.S. 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.”

The FDA issued several recommendations for both women and for doctors. For women, the recommendations include, “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.”

To doctors, the FDA makes the recommendation that 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.”

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