Nipple Aspirate Test Not a Replacement for Mammography

The US Food and Drug Administration (FDA; Silver Spring, MD, USA) is not aware of any valid scientific data to show that a nipple aspirate test alone is an effective screening tool for any medical disorder including the early detection of breast cancer or other breast disease.

The FDA, other public health agencies, and US medical and professional societies agree that mammography is the most effective method for detecting breast cancer in its earliest, most treatable stages. These organizations include the American Cancer Society, the American College of Radiology, the Centers for Disease Control and Prevention, the US National Cancer Institute, and the Society for Breast Imaging. The US National Comprehensive Cancer Network (NCCN) 2013 guidelines state that the clinical usefulness of nipple aspiration is still being evaluated and it should not be used as a breast cancer screening technique.

A nipple aspirate device is a type of pump used to gather fluid from a woman's breast. A nipple aspirate test can determine whether the fluid collected from the breast contains any abnormal cells.

Certain manufactures are endorsing the use of nipple aspirate tests as a standalone assessment tool for screening and diagnosing breast cancer, claiming they are an alternative to biopsy or mammography. They also assert that a nipple aspirate test can identify precancerous abnormalities and diagnose breast cancer before undergoing mammography with only a sample of a few cells. The FDA is alarmed that women will believe these deceptive claims about a nipple aspirate test and not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious adverse health consequences.

Possible health consequences include false-negative test results and false-positive test findings. False-negative results may lead to delayed diagnosis and/or delayed treatment of breast cancer, with increased risk of serious illness or death. False-positive findings may lead to needless patient anxiety, along with unnecessary additional testing and treatment.

Recommendations for patients: (1) The FDA reported that patients should remember that a nipple aspirate test, such as Atossa Genetics, Inc.’s (Seattle, WA, USA) mammary aspiration specimen cytology test (MASCT) and/or ForeCYTE breast health test systems, or the HALO breast Pap test, is not a substitute for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself for breast cancer screening or diagnosis. (2) If an individual had a nipple aspirate test as a standalone evaluation tool for screening and diagnosing breast cancer, she should request a mammogram from her healthcare provider to get accurate findings. (3) Undergo regular mammograms according to screening guidelines or as recommended by the healthcare provider.

Recommendations for healthcare providers: (1) Do not use a nipple aspirate test as a substitute for mammography or by itself for breast cancer screening or diagnosis. (2) The FDA has taken action against specific manufacturers promoting nipple aspirate tests as a stand-alone strategy for screening and diagnosing breast cancer.

In February 2013, the FDA sent a warning letter to Atossa Genetics, Inc. for the marketing and promotion of a nipple aspirate test for uses that had not received FDA marketing clearance or approval. In this warning letter, the FDA instructed the manufacturer to immediately stop making inappropriate statements about nipple aspirate tests.

In October 2013, Atossa Genetics, Inc. initiated a voluntary recall to remove the ForeCYTE breast health test and the Mammary aspiration specimen cytology test (MASCT) from the market. The FDA classified this recall as class I, which means that the product is dangerous or defective and has a reasonable chance of causing serious health problems or death.

The FDA will continue to monitor the promotional activity of nipple aspirate test manufacturers, and keep the public and practitioners informed as new information becomes available.

Related Links:
US Food and Drug Administration
Atossa Genetics