FDA Warns Against Ovarian Cancer Screening Tests

The US Food and Drug Administration (FDA) is alerting women and their medical care providers to the risks of using tests that are marketed as screening tests for ovarian cancer. The FDA says these tests should not be used because they have a high number of false results.

Screening tests look for cancer in people who don’t have any symptoms. For some cancer types, screening tests are available that can find cancer early, when it’s easier to treat. Some tests can even find growths and remove them before they have a chance to turn into cancer. But there are no reliable screening tests yet that can find ovarian cancer.

The FDA has issued a safety communication that warns of risks associated with the use of tests that claim they can screen for ovarian cancer. It says women and their doctors may be misled by the claims and make treatment decisions that rely on inaccurate test results.

Some women may get test results that suggest they have ovarian cancer, even when no cancer is present. This is called a false-positive. This may lead to unneeded medical tests and even surgery, which carry risks. Some women may get test results that say they don’t have ovarian cancer, even though they do. This is called a false-negative. This may prevent women from getting the care they need to treat the cancer.

The safety communication includes a special warning for women with an increased risk for ovarian cancer due to family history or certain gene mutations. The FDA says a test result that shows no cancer doesn’t in fact reduce the risk for these women. They could still develop ovarian cancer in the future. The FDA recommends that medical providers consider referring women at high risk for ovarian cancer to a genetic counselor, gynecological oncologist, or other specialist.

Researchers exploring solutions

A good screening test for ovarian cancer is badly needed because symptoms alone are not reliable indicators of ovarian cancer. Often, symptoms don’t appear until the cancer has spread and it’s harder to treat. And when symptoms do appear, they are usually similar to symptoms of much less serious problems. The most common symptoms are abdominal swelling or bloating, pelvic pressure or abdominal pain, trouble eating or feeling full quickly, and urinary symptoms, such as having to go right away or having to go often.

But so far, no screening test has been shown to lower the number of deaths from ovarian cancer. Two large studies of screening – one in the United States and one in the United Kingdom – found that women who got screening tests did not live longer and were not less likely to die from ovarian cancer.

Researchers are now testing new ways to screen women for ovarian cancer, and a national repository for blood and tissue samples from ovarian cancer patients is being established to aid in these studies.

In the meantime, it’s important for women who have symptoms like those above, especially if they have them almost daily for more than a few weeks, to see a health care professional – preferably a gynecologist.

FDA-approved OVA1 test is not a screening test

Women who have already been found to have an ovarian tumor may receive a test called OVA1. This test has been approved by the FDA, but it is not a screening test. It’s a way to help women and their medical providers predict whether an ovarian tumor is likely to be cancerous, which could in turn affect their treatment.

The American Cancer Society medical and editorial content team
Our team is made up of doctors and master’s-prepared nurses with deep knowledge of cancer care as well as journalists, editors, and translators with extensive experience in medical writing.


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