March 22, 2018 |
Breast Cancer Screening - Nipple Aspirate Test Is Not An Alternative To Mammography
December 12, 2013  | 

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 Health Care Providers:

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

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. Continue>

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