FDA Warns Against Using Ovarian Cancer Screening Tests


September 07, 2016

Clinicians should not recommend the use of ovarian cancer screening tests on the market because their propensity for inaccurate results may lead women to either forgo needed care, or opt for unnecessary care, the US Food and Drug Administration (FDA) announced today.

"Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for (the cancer) without a high number of inaccurate results," the FDA said in a safety communication. Numerous companies that market these tests for asymptomatic women claim otherwise.

The agency noted that it has yet to approve or otherwise clear any screening tests for ovarian cancer. However, unapproved screening tests for ovarian cancer and other diseases have been able to proliferate because they are designed, manufactured, and used within a single lab company.

The FDA traditionally has exercised "enforcement discretion" for such lab developed tests (LDTs) — in other words, waived any vetting — because they used to be relatively simple, confined to a local lab, and deemed low risk. However, the rise of complex and widely available LDTs for serious conditions such as cancer has prompted the FDA recently to require some of their makers — 23andMe and Theranos are examples — to obtain a form of clearance.

In the case of ovarian cancer, the FDA worries that a false negative may cause a woman not to seek surgery or other treatments, or else put it off. Likewise, a woman with a false positive may undergo more tests and even unnecessary surgery, always with the risk for complications.

Screening tests on the market also may prove harmful to women at a high risk for ovarian cancer based on gene mutation and family history, according to the agency.

"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 FDA stated. "Yet, this group of women is still at high risk of developing ovarian cancer later based on their gene mutation and/or family history. 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."

The agency advises clinicians to refer such high-risk women to a genetic counselor, a gynecologic oncologist, or some other appropriate specialist.

More information on today's announcement is available on the FDA website.

Follow Robert Lowes on Twitter @LowesRobert


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