Ovarian Cancer Screening: A Warning

FDA issues warning about ovarian cancer screening tests

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(RxWiki News) The US Food and Drug Administration (FDA) has issued a warning about tests being marketed to screen for ovarian cancer.

The recent warning was issued because there are currently no ovarian cancer screening tests that the FDA has approved. In fact, the available data do not show these screening tests are accurate or reliable, particularly in women without any symptoms.

The FDA is concerned that women and their health care providers may rely on inaccurate results and make treatment decisions based on them. 

Although the data is not available to show that these screening tests work, many companies are marketing their tests to do just that. Abcodia Incorporated's Risk of Ovarian Cancer Algorithm (ROCA) test is being marketed as a test that can screen and detect ovarian cancer before symptoms appear, as well as increase the chances of patient survival. However, existing data does not support these claims. 

These results could go both ways — a false positive or a false negative:

  • False positive: A woman's test result may indicate ovarian cancer even though cancer is not present. In this case, it is likely there will be unnecessary additional testing and surgery. 
  • False negative: A woman's test result may not show cancer is present when cancer is, in fact, present. In this case, women may delay treatment, such as surgery. This becomes more important in those women at a high risk of developing ovarian cancer.   

Women with a BRCA1 or BRCA2 gene mutation and/or a family history of the condition are at a high risk of developing ovarian cancer. Women who are at a high risk and use an unproven ovarian cancer screening test may receive test results that show there is no cancer present, but they are still at a high risk for developing ovarian cancer.

That said, the FDA recommends that women who are at a high risk for developing ovarian cancer should not use any of the tests that claim to screen for/detect ovarian cancer. 

Women should not rely on test results from these screening tests to make health or treatment decisions, the FDA said. 

Speak to your doctor about your risk for developing ovarian cancer, as well as ways to reduce your risk. 

Last Updated:
September 12, 2016