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FDA Issues Warning on Nipple Aspirate Test for Breast Cancer

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FDA warning about nipple aspirate test for breast cancer Ivelin Radkov/PhotoSpin

Most women would agree that getting a mammogram isn’t much fun. In fact, discomfort is one of the most cited excuses women give for not getting regularly screened for breast cancer, the second most common form of cancer in women.

So when some companies started promoting an easier, more comfortable alternative to mammography some women jumped with glee.

The stand-alone diagnostic test, called a nipple aspirate, has been touted as “literally a PAP test for breast cancer,” for women age 18 and older, according to one company’s literature. The claim was that nipple aspirate tests could detect breast cancer in its earliest and most treatable stages.

The only problem is that the claims are clinically unsubstantiated and could put women at grave risk, according the U.S. Food and Drug Administration (FDA).

The FDA is alerting the public that a nipple aspirate test should not replace mammography, other breast imaging tests, or breast biopsy, nor should the nipple test be used alone to screen for or diagnose breast cancer.

"Our fear is that women will forgo a mammogram and have this test instead. This could result in serious health consequences if breast cancer goes undetected,” said David L. Lerner, M.D., a medical officer at the FDA and a specialist in breast imaging.

A nipple aspirate test uses a breast pump to collect fluid from a woman’s nipples to screen for abnormal and potentially cancerous cells.

In a safety alert, the FDA recommends that women who’ve received a nipple aspirate test as a form of breast cancer screening should also have a mammogram according to screening guidelines or as recommended by their doctor, and should talk to their health care professional about whether additional tests are needed.

“FDA is unaware of any valid scientific data to show that nipple aspirate tests, when used on their own, are an effective screening tool for any medical condition, including the detection of breast cancer or other breast disease,” Lerner said in the written warning.

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