There's no good evidence these widely used tests are reliable, the FDA warns. Here's what experts recommend instead.
Don’t rely on screening tests for ovarian cancer to make decisions about your health, the U.S. Food and Drug Administration is warning women. The FDA is also telling doctors not to use these tests on women at normal risk for the disease—and to be aware that screening higher-risk patients has no proven benefit, either.
These recommendations, published on the FDA’s website, are in response to marketing claims made by companies that currently sell products they say can screen for and diagnose the disease. “Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results,” the statement reads.
Health experts are especially concerned about women at increased risk for ovarian cancer due to a family history or other factors. “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,” the statement reads. “The FDA believes that women at high risk for developing ovarian cancer should not use any currently offered test that claims to screen for ovarian cancer.”
Then there’s the fact that any woman, regardless of her risk factors, can receive inaccurate results from these tests. Some will test positive even though no cancer is present, and may choose to undergo unnecessary surgery or additional, invasive tests. Even more concerning, others will test negative even when they do have cancer—leading them to delay or forego potentially lifesaving treatments.
Instead of being misled by marketing claims, the FDA recommends that women talk to their doctors about ways to reduce their risk of ovarian cancer—especially if they have a family history or know that they carry a genetic mutation that raises their risk. And doctors caring for high-risk patients should consider referring those women to a genetic counselor or gynecologic oncologist, the Agency says, for more specialized care.
No major medical group recommends the use of ovarian cancer screening tests, including a heavily marketed blood test known as the ROCA (Risk of Ovarian Cancer Algorithm) test. This product, and others like it, screen for elevated levels of the protein CA 125 in the blood. In June, the Ovarian Cancer Research Fund published an editorial suggesting that it was premature to recommend such tests, and noted that many experts were "uncomfortable" with the tests being marketed directly to consumers.
It may see strange that these tests are even allowed on the consumer market if the FDA says they don’t work. But while the FDA does regulate medical devices and certain types of diagnostic tests, Forbes reports, it has never enforced regulatory requirements for “laboratory-developed tests" (LDTs), or tests manufactured and used in a single laboratory. In the past, LDTs were used only in local labs for rare conditions. But in recent years they’ve become more widely available and used to diagnose common conditions.
Ovarian cancer is the fifth leading cause of cancer-related death among American women; in 2016, more than 22,000 women will be diagnosed with the disease and more than 14,000 will die. Women over 50, those who have a family history of the disease, and those who have the BRCA1 or BRCA2 gene mutation (also known as the breast cancer gene) are at higher-than-normal risk.
While there is currently no accurate screening test for ovarian cancer, scientists are working hard to develop more reliable means of detection. Until then, a woman's best bet is to live a healthy lifestyle and get her regular pelvic exam; early-stage ovarian cancers are rarely—but sometimes—found during these appointments. And while early ovarian cancer doesn't often cause symptoms, women should still be aware of subtle, easy-to-miss signs that can sometimes lead to a diagnosis.