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FDA: Nipple Aspirate, a Breast Cancer Screening Test is Not an Alternative to Mammogram

Dec 13, 2013

The U.S. Food and Drug Administration (FDA has issued a Safety Communication alerting the public and health care providers that a nipple aspirate test (a breast screening test) is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer.

In a nipple aspirate test, a pump is used to collect fluid from a woman's breast, which is then tested to determine if it contains abnormal cells. Some test manufacturers promote the nipple aspirate test as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming the test is an alternative to biopsy or mammography. But the FDA said it is not aware of any valid scientific data showing that a nipple aspirate test by itself is an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease.

The manufacturers also claim that a nipple aspirate test can detect pre-cancerous abnormalities and diagnose breast cancer earlier than mammography can detect it, using just a few cells. The FDA is concerned that women will believe these misleading claims about a nipple aspirate test and not get mammograms and/or other needed breast imaging tests or biopsies, possibly leading to serious adverse health consequences.

The FDA cautions about the health consequences of both false positive and false negative test results. False negative results may delay diagnosis and/or treatment for a woman who actually has breast cancer, increasing her risk of serious illness or death. A false positive—indicating cancer where it is not present—may lead to needless anxiety, along with unnecessary additional testing and treatment.

The National Comprehensive Cancer Network (NCCN) 2013 guidelines state that the clinical utility of nipple aspiration is still being evaluated and the test should not be used as a breast cancer screening technique, according to the FDA communication.

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