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FDA Warns Against Ovarian Cancer Screening Tests: What Factors Determine Women’s Risk Levels For The Disease?

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The U.S. Food and Drug Administration (FDA) has warned women and physicians against the use of screening tests available in the market for detection of ovarian cancer.

Ovarian cancer is the fifth leading cause of cancer-related deaths in women in the United States and according to the National Cancer Institute, as many as 22,000 women in the country will be diagnosed with ovarian cancer in 2016.

According to the FDA's report released on Wednesday, Sept. 7, while numerous companies have come up with ovarian cancer screening tests, no method is sensitive enough to screen the cancer accurately and produce reliable results. The tests may deceive users and physicians may limit them from making appropriate treatment decisions.

"Based on the FDA's review of available clinical data from ovarian cancer screening trials and recommendations from health care 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," says the FDA in its press release.

Some women who are not at risk of ovarian cancer may develop health complications because of unnecessary tests and surgeries as a result of a false positive report from screening tests. On the other hand, a false negative result for women at high risk of cancer may delay them from receiving appropriate treatment, resulting in serious complications.

In addition, the FDA has also warned women at elevated risk of cancer based on family history and gene mutation not to use the tests available in the market for screening or making their treatment decisions. They are instead advised to visit their doctor to discuss how to reduce their risk of developing ovarian cancer. Doctors in turn are recommended by the FDA to refer those at high risk of developing the disease to a gynecologic oncologist or genetic counselor.

Though there is no exact way to determine whether a woman will develop ovarian cancer, some factors are believed to increase the risk of cancer.

In general, aging puts a woman at increased risk of cancer and therefore elderly and middle-aged women are slightly prone to ovarian cancer. Women with a family history of ovarian cancer and those with BRCA1 or BRCA2 gene mutation are also at high risk of ovarian cancer.

Women that had melanoma, breast, cervical and colorectal cancer and those that had trouble conceiving or had never given birth are also at risk of ovarian cancer. Women from an Eastern European (Ashkenazi) Jewish background are also more likely to develop ovarian cancer compared to women from other ethnic groups. Women with endometriosis and those that had estrogen supplements without progesterone for 10 years or more may also have an elevated risk of ovarian cancer.

However, women should note that risk factors mean increased risk, and that having one or more of the factors doesn't mean they would certainly have cancer. The CDC recommends that women talk to their doctors about their cancer risk.

Photo: Servier Medical Art | Flickr

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