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FDA warns patients, physicians against using ovarian cancer screening tests
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The FDA issued a warning to alert patients and physicians that screening tests for ovarian cancer have been found to be unreliable and could lead to false diagnoses.
Although a variety of marketed tests exist that claim to screen for and detect ovarian cancer, no current screening tests have effectively demonstrated high sensitivity without a large number of inaccurate results.
Women and their physicians may be misled by false claims and rely on inaccurate data to make treatment decisions, according to the FDA.
“For example, some women may receive test results that suggest ovarian cancer even though no cancer is present (a false-positive),” the safety communication said. “These women may undergo additional medical tests and/or unnecessary surgery, and may experience complications related to both. Or, test results may not show ovarian cancer even though cancer is present (a false-negative), which may lead women to delay or not seek surgery or other treatments for ovarian cancer.”
The FDA also recommended against the use of ovarian cancer screening tests for women at high risk for developing ovarian cancer. Inaccurate test results could delay effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer.
“For instance, these women and their doctors may not take appropriate actions to reduce their future risk if they rely on a result that shows no cancer currently present. Yet, this group of women is still at high risk for developing ovarian cancer later based on their gene mutation and/or family history,” the safety communication said.
The FDA recommended all women:
- be aware that there is currently no safe and effective ovarian cancer screening test;
- not rely on ovarian cancer screening test results to make health or treatment decisions; and
- talk to their physician about ways to reduce the risk for developing ovarian cancer, particularly in patients with a family history of ovarian cancer, or those with BRCA1 or BRCA2 genetic mutations.
In addition, the FDA suggested physicians avoid recommending or using ovarian cancer screening tests in the general population of women and to consider referring women at high risk for developing ovarian cancer to a genetic counselor or gynecologic oncologist, or other appropriate health care providers for more specialized care.