In a Safety Communication this week, the U.S. Food and Drug Administration (FDA has alerted the public and health care providers that a nipple aspirate test is not an alternative to mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer.
The nipple aspirate test uses a pump to collect fluid from a woman’s breasts and the fluid is tested to see 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 and they claim the test is an alternative to biopsy or mammography. But the FDA said it knows of no valid scientific data to show that the 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 the test can detect pre-cancerous abnormalities and diagnose breast cancer earlier than it can be detected by mammography. 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 communication warns of possible the health consequences from both false positive and false negative test results. A false negative result may delay diagnosis and/or treatment for a woman who actually has breast cancer, increasing the 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.
According to the FDA, the 2013 guidelines from the National Comprehensive Cancer Network (NCCN) state that the nipple aspirate test is still being evaluated and should not be used as a breast cancer screening technique.
