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Gene Tests to Identify Ovarian Cancer Have Little Clinical Value

Many genomic tests that are currently used to diagnose and guide treatment of ovarian cancer are not shown to decrease the number of women who die from the disease or improve their quality of life, //according to a new evidence report supported by a partnership of the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention’s Division of Cancer Prevention and Control, and CDC’s National Office of Public Health Genomics.

Ovarian cancer causes more deaths than any other cancer of the female reproductive system. More than 20,000 women are diagnosed with the disease annually, and approximately 15,000 die from it. The risk for ovarian cancer increases with age and most often is diagnosed in white women over the age of 50. If diagnosed during stage I, ovarian cancer has a survival rate of over 90 percent. However, most cases are diagnosed in advanced stages, when the cancer has spread to other organs.

Physical exams, ultrasounds, and other routine screening efforts for reducing the number of women affected by the disease, and in turn the number who die from it, have been unsuccessful compared with similar efforts aimed at other causes of cancer deaths in women. Because current strategies have not proven to be effective, there is tremendous interest in identifying the disease in its earliest stages by looking at genes, gene expression levels, proteins, and tumor markers. These tests focus on (1) detecting a gene-based tumor marker, such as CA-125, or (2) identifying genetic mutations such as BRCA1 and BRCA2 that indicate increased risk for developing cancer, or (3) identifying genetic changes that predict response to therapy in women with ovarian cancer.

Researchers performed a comprehensive review of the literature and found few studies evaluated genetic tests other than CA-125 or BRCA1 and BRCA2 to diagnose ovarian cancer or identify women at risk. Among the tests evaluated in the report, the researche
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