FDA: Nipple Aspirate Test No Substitute for Mammogram

The US Food and Drug Administration (FDA) is alerting women and their doctors not to use nipple aspirate tests in place of mammograms or other tests that screen for or diagnose breast cancer.

A nipple aspirate test uses a device – similar to breast pumps used by nursing mothers – to collect a small amount of fluid from the nipple. The fluid comes from cells that line the inside of milk ducts in the breast. These cells are responsible for most breast cancers, and researchers are studying whether changes in those cells can help find breast cancer earlier, when it’s easier to treat. However, the FDA says there is so far no scientific evidence that this test by itself can detect breast cancer or any other breast condition.

"FDA's concern is that the nipple aspirate test is being touted as a stand-alone tool to screen for and diagnose breast cancer as an alternative to mammography," said David L. Lerner, MD, an FDA medical officer and a specialist in breast imaging, in a statement on the FDA’s website. "Our fear is that women will forgo a mammogram and have this test instead."

Test recalled

In October 2013, Atossa Genetics, Inc. voluntarily recalled its nipple aspirate test ForeCYTE Breast Health Test after the FDA warned its claims about the test were not proven. The company had claimed the test could help women determine their risk level for breast cancer, and called it “literally a Pap smear for breast cancer.”

According to the FDA, the ability of a Pap smear to screen for cervical cancer is supported by extensive clinical studies over many years, while the ability of a nipple aspiration test to screen for breast cancer has no evidence to support it. Lerner said one reason the test is flawed is that it may conclude that a woman is healthy based on results from just a few cells or none at all. "The test may be missing cancers and giving women dangerous false assurance," said Lerner.

Missing a cancer diagnosis is called a false negative test result, which may lead to delayed diagnosis and treatment. The FDA is also concerned about false positives, which indicate the presence of breast cancer when none exists. This can lead to unnecessary testing and treatment, as well as worry and stress.


The FDA recommends that women who have had 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.

The American Cancer Society recommends women should be screened for breast cancer through annual mammograms and breast exams beginning at age 40 and continuing for as long as they are in good health.

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