Breast Cancer Screening - Nipple Aspirate Test Is Not An Alternative To Mammography: FDA Safety Communication

Date Issued: December 12, 2013

Audience:

• Women
• Health Care Providers
• Cancer Advocacy Organizations
• National Association of Attorneys General

Medical Specialties: Radiology, Pathology, Internal Medicine, Obstetrics/Gynecology, Oncology, Nursing, General and Family Practice, Breast Surgery, Acupuncture, Osteopathy, Chiropractic.

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

Purpose:
The FDA is alerting the public, including women and health care providers, that a nipple aspirate 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.  The FDA is not aware of any valid scientific data to show 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 FDA, other public health agencies, and national 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 National Cancer Institute, and the Society for Breast Imaging. The National Comprehensive Cancer Network (NCCN) 2013 guidelines state that the clinical utility of nipple aspiration is still being evaluated and it should not be used as a breast cancer screening technique.

Summary of Problem and Scope:
Certain manufactures are promoting the use of nipple aspirate tests as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming they are an alternative to biopsy or mammography. They also claim that a nipple aspirate test can detect pre-cancerous abnormalities and diagnose breast cancer before mammography with just a sample of 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. This may lead to serious adverse health consequences.

Possible health consequences include false negative test results, indicating the absence of breast cancer when cancer exists, and false positive test results, indicating the presence of breast cancer when none exists.  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 results may lead to needless patient anxiety, along with unnecessary additional testing and treatment. 

Recommendations for Patients:

• Remember that a nipple aspirate test, such as Atossa Genetics Inc.'s 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.
• If you have had a nipple aspirate test as a stand-alone evaluation tool for screening and diagnosing breast cancer, you should request a mammogram from your health care provider to get accurate results.
• Undergo regular mammograms according to screening guidelines or as recommended by your health care provider.

Recommendations for Health Care Providers:

• Do not use a nipple aspirate test as a substitute for mammography or by itself for breast cancer screening or diagnosis.

FDA Activities:
The FDA has taken action against certain manufacturers promoting nipple aspirate tests as a stand-alone tool 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 claims 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.  

Other Resources:

• FDA Consumer Update – Nipple Aspirate No Substitute for Mammogram
• Class I Recall: Atossa Genetics Mammary Aspiration Specimen Cytology Test (MASCT) System Kit and the ForeCYTE Breast Health Test - Marketing Without Approval or Clearance
• National Cancer Institute – Breast Cancer Screening
• National Cancer Institute at the National Institutes of Health – Tests that examine the breast are used to detect (find) and diagnose breast cancer
• FDA's Mammography Quality Standards Act and Program (MQSA)
• FDA's Women's Health Topics: Mammography

Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.