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News From the Food and Drug Administration
October 18, 2016

Ovarian Cancer Screening Tests Don’t Pass Muster

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Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;316(15):1538. doi:10.1001/jama.2016.14614

Physicians and their women patients shouldn’t use screening tests that claim to detect ovarian cancer, the FDA has cautioned.

“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,” FDA officials said in a statement.

The agency’s safety alert is based on its review of clinical data from ovarian cancer screening trials, recommendations from professional health care groups, and the US Preventive Services Task Force. Tests that produce false-positive results may send some women for additional testing or unnecessary surgery, both of which can cause complications. Conversely, false-negative results that miss existing cancers may keep women from seeking treatment.

Unproven screening tests can harm women who are at increased risk for ovarian cancer if their physician relies on a test result showing that a patient is cancer-free and then fails to take steps to reduce her future risk of developing ovarian cancer. “[T]his group of women is still at high risk of developing ovarian cancer later based on their gene mutation and/or family history,” FDA officials said.

The agency recommends that physicians refer women who are at high risk of developing ovarian cancer, including those with BRCA mutations, to a genetic counselor, gynecologic oncologist, or other appropriate health professional for more specialized care.

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