The U.S. Food and Drug Administration (FDA) has issued a warning on screening tests for ovarian cancer, saying women and their doctors should be cautious when making treatment decisions based on any test result because there is currently no proven method of screening ovarian cancer.
In a statement issued on Wednesday, Sept. 7, the agency said that doctors should not recommend the use of ovarian cancer screening tests because inaccurate results may cause women to either forgo crucial treatment or get unnecessary care.
The most widely used screening test in the market is the CA 125, which measures the amount of the protein CA 125 present in the blood.
Although certain cancers, which include ovarian cancer, may boost CA 125 levels in the blood, results of the test are far from foolproof since many non-cancerous conditions may also increase the level of the protein. Erroneous test results may lead healthy women to undergo unnecessary follow-up.
Findings of a 2015 study involving 200,000 women over a course of five years suggested that the test and another ovarian screening test, Abcodia's Risk of Ovarian Cancer Algorithm, or ROCA, can potentially reduce mortality from ovarian cancer by 20 percent and may further reduce it in the decade following cancer diagnosis.
Despite this, the FDA does not recommend any currently offered test to screen for the disease. In the case of CA 125 test, which is being used extensively for screening ovarian cancer, the American Cancer Society said that no major medical or professional organization has recommended the routine use of this test to screen for ovarian cancer.
The FDA in particular showed concern for those with increased risk for ovarian cancer who may opt out of taking necessary actions to reduce their likelihood of developing the disease because of results that do not show the presence of cancer.
"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," the FDA advised physicians in its statement.
For women with increased risk for ovarian cancer, the FDA said clinicians should refer them to a genetic counselor, a gynecologic oncologist or other appropriate specialist.
The National Cancer Institute estimates that more than 22,000 women between 35 and 74 years old will be diagnosed with ovarian cancer this year.