FDA warns against nipple test for breast cancer screening

December 14, 2013
FDA warns against nipple test for breast cancer screening
Mammogram is still the gold standard, agency says.

(HealthDay)—A new test marketed as an alternative to a mammogram for breast cancer detection is not an effective screening TOOL, U.S. health officials say.

With the nipple aspirate test, a collects fluid from a woman's nipple. The fluid is then examined for abnormal and potentially cancerous cells. The test is advertised as easier, more comfortable and less painful than .

However, there is no proof to support claims that the test can detect , said Dr. David Lerner, a medical officer at the U.S. Food and Drug Administration and a breast imaging specialist.

"FDA's concern is that the nipple aspirate test is being touted as a standalone tool to screen for and diagnose breast cancer as an alternative to mammography," Lerner said in an agency news release. "Our fear is that women will forgo a mammogram and have this test instead."

Skipping a mammogram could put a woman's health and life at risk if breast cancer goes undetected, Lerner warned.

He said there is no scientific evidence that the nipple aspirate test, when used on its own, is an effective screening tool for breast cancer or any other medical condition. The test is still being studied to determine if it might be useful in combination with other methods to screen for disease.

"The bottom line is that women should not rely solely on these nipple aspirate tests for the screening or diagnosis of breast cancer," Lerner said. "Mammography is still the gold standard."

In October, Atossa Genetics pulled its nipple aspirate test—called the ForeCYTE Breast Health Test—off the market after being warned by the FDA that its claims about the test were unsubstantiated. The company claimed the test was "literally a Pap smear for breast cancer." Pap smears are a standard test for cervical cancer.

Women who have had a nipple aspirate as a form of should also have a mammogram, according to guidelines or as recommended by their doctor. Also, they should talk to their doctor about whether additional tests are needed, the FDA said.

One in eight U.S. women will develop breast cancer in her lifetime. The disease is the second leading cancer killer of women in the country.

Explore further: A simple blood test could be used to detect breast cancer

More information: The U.S. National Cancer Institute has more about breast cancer screening.

Related Stories

A simple blood test could be used to detect breast cancer

October 1, 2012

A simple blood test could one day be a more accurate way to test for the early signs of breast cancer than using mammograms to spot a lump say researchers today, as Breast Cancer Awareness Month gets underway.

Individualized breast cancer screening catches more cancer

August 12, 2013

(HealthDay)—A breast cancer screening program tailored to participants' individual risk profiles has a higher-than-expected breast cancer detection rate in 40- to 49-year old women, according to a pilot study published ...

Recommended for you

Elephants provide big clue in fight against cancer

October 9, 2015

Carlo Maley spends his time pondering pachyderms—and cactuses and whales, and a wide array of non-human species—all in pursuit of the answer to this question: Why do some life forms get cancer while others do not?

Compound doubles up on cancer detection

October 8, 2015

Tagging a pair of markers found almost exclusively on a common brain cancer yields a cancer signal that is both more obvious and more specific to cancer, according to a study published last week in the Proceedings of the ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.