FDA: Clinicians May Be Misled by Ovarian Screening Test Claims

The FDA is concerned about marketed tests that claim to screen for and detect ovarian cancer
The FDA is concerned about marketed tests that claim to screen for and detect ovarian cancer

Currently, tests that can accurately screen for the disease are unavailable although a number of companies have marketed tests that claim to screen for and detect ovarian cancer. The FDA is concerned that both clinicians and patients may be misled by these tests and rely on inaccurate results to make treatment decisions; this is especially concerning for women at high risk for developing ovarian cancer. 

The Risk of Ovarian Cancer Algorithm test, marketed by Abcodia Incorporated, is an example of a test being marketed with claims that it can screen for and detect ovarian cancer before symptoms appear and increase the chance for survival, however no data is available to support these claims. 

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Specific for clinicians, the FDA recommends the following:

  • 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.

Unlike screening tests for breast, colon, and cervical cancers, the FDA is unaware of any valid scientific data to support the use of any test for ovarian cancer. The FDA will alert the public as new information about ovarian cancer screening tests becomes available.

For more information visit FDA.gov.

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