The FDA is warning women and their physicians not to use ovarian cancer screening tests because test results are not reliable and may cause delays in treatment.
Currently, there is no safe and effective ovarian cancer screening test because none are sensitive enough to reliably screen for ovarian cancer without a high number of false results.
False-negative test results cause a woman who actually has ovarian cancer to not receive needed treatment. False-positive results cause a healthy woman to undergo more testing or unnecessary surgery with risks for complications for a cancer that doesn’t exist.
Several companies have marketed tests that claim to screen for and detect ovarian cancer. In a recent safety alert warning about these tests, the FDA said “women and their physicians may be misled by such claims and rely on inaccurate results to make treatment decisions.”
There are also fears that women at high risk for the disease may rely on inaccurate testing instead of working on prevention.
According to the American Cancer Society, ovarian cancer begins in the ovaries, which are reproductive glands found only in women. Ovarian cancer occurs when abnormal cells in or near the ovaries grow and form a cancerous tumor. Symptoms rarely appear until the cancer has spread and early detection is difficult.
In the U.S., ovarian cancer is the fifth leading cause of cancer-related death among women. The National Cancer Institute says that in 2016, more than 22,000 women will be diagnosed with ovarian cancer. Those at highest risk are women who have reached menopause, women who have a family history of ovarian cancer and women with specific genetic mutations.
Women are encouraged to talk to their doctors about ways to reduce their risk of developing ovarian cancer, especially if there is a family history of ovarian cancer or they have BRCA genetic mutations.
Physicians are asked not to recommend or use tests that claim to screen for ovarian cancer in the general population of women because testing higher-risk patients for ovarian cancer has no proven benefit and is not a substitute for preventive actions that may reduce their risk.
Physicians are instead asked to consider referring at-risk women, including those with BRCA mutations, to a genetic counselor or gynecologic oncologist or other appropriate health care provider for more specialized care.
The Medical Board of California shared the FDA safety alert with its licensed physicians.
“The Medical Board’s primary mission is consumer protection and this type of information is extremely valuable in achieving that goal,” said Kim Kirchmeyer, Medical Board executive officer.
The California State Board of Pharmacy also helped spread the word to licensed pharmacists.
“We believe women who are considering such tests should review the concerns of the FDA,” said Virginia Herold, Board of Pharmacy executive officer.
To view the FDA safety alert, click here.