FDA Alert Concerning Ovarian Cancer Screening Tests

On September 9^th, the U.S. Food and Drug Administration (FDA), through its Medwatch Program, issued a Safety Communication to alert women and their healthcare providers about the inaccuracies of currently marketed ovarian cancer screening tests and the harm that can result from such inaccuracies, i.e. “false-negatives” and “false-positive” test results. According to the FDA Alert:

"FDA is concerned that women and their physicians may be misled by such claims and rely on inaccurate results to make treatment decisions. Based on the FDA’s review of available clinical data from ovarian cancer screening trials and recommendations from healthcare professional societies and the U.S. Preventive Services Task Force, available data do not demonstrate that currently available ovarian cancer screening tests are accurate and reliable in screening asymptomatic women for early ovarian cancer. For example, some women may receive test results that suggest ovarian cancer even though no cancer is present (a false-positive). 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.”

In its Alert, the FDA makes various recommendations for both physicians and women, the first of which is not to rely on currently-marketed ovarian cancer screening tests for any reason.

For women, including those at increased risk of developing ovarian cancer:

• Be aware that there is currently no safe and effective ovarian cancer screening test.
• Do not rely on ovarian cancer screening test results to make health or treatment decisions.
• Talk to your doctor about ways to reduce your risk of developing ovarian cancer, especially if you have a family history of ovarian cancer, or have the BRCA1 or BRCA2 genetic mutations.

If you have questions or concerns about your risk of developing ovarian cancer or about what you can do to minimize that risk, we urge you to contact your healthcare provider and discuss those questions and concerns with him/her. If you do not currently have a healthcare provider, contact your local hospital, clinic, or medical association and ask for the names of doctors (gynecologists) and clinics who are accepting new patients.