BlueCross BlueShield of Tennessee Medical Policy Manual

Cytologic Evaluation in Breast Cancer Risk Assessment


The analysis of epithelial cells from breast duct fluid is intended to assess an individual's risk for breast cancer. A variety of techniques exist to obtain epithelial cells for cytologic evaluation, including random periareolar fine needle aspiration, nipple aspirate fluid, ductal lavage and suction.

Most breast cancers develop from the epithelial cells that line the breast ducts. Because abnormalities in these tissues may indicate an elevated risk of developing breast cancer, histologic examination of these tissues has been proposed as an aid to identify individuals at risk. The clinical utility of these tests (e.g. FirstCyte™ Breast Test, HALO Nipple Aspirate Fluid collection system) is still being evaluated.




There remains insufficient evidence to evaluate the impact of this technology on net health outcomes.


American College of Obstetricians and Gynecologists. (2017, September).  ACOG Practice bulletin #182: hereditary breast and ovarian cancer syndrome. Retrieved July 24, 2018 from

Danforth, D., Warner, A., Wangsa, D., Ried, T., Duelli, D., Filie, A., & Prindiville, S. (2015). An improved breast epithelial sampling method for molecular profiling and biomarker analysis in women at risk for breast cancer. Breast Cancer: Basic and Clinical Research, 9, 31-40. (Level 4 evidence)

De Groot, J.S., Moelans, C.B., Elias, S.G., Hennink, A., Verolme, B., Suijkerbuijk, M., et al. (2015). Repeated nipple fluid aspiration: compliance and feasibility results from a prospective multicenter study. PLoS One, 10 (5), e0127895.

Hornberger, J., Chen, S.C., Li, Q., Kakad, P., & Quay, S.C. (2015). Proliferative epithelial disease identified in nipple aspirate fluid and risk of developing breast cancer: a systematic review. Current Medical Research and Opinion, 31 (2), 253-262. (Level 1 evidence)

National Comprehensive Cancer Network. (2019, May). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Breast cancer screening and diagnosis. v 1.2019. Retrieved July 8, 2019 from the National Comprehensive Cancer Network.

U.S. Food and Drug Administration. (2013). Nipple aspirate test: safety communication – breast cancer screening test is not an alternative to mammography. Retrieved July 8, 2019 from

U.S. Preventive Services Task Force (USPSTF). (2016). Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Retrieved July 8, 2019 from 


MOST RECENT REVIEW DATE:  8/8/2019         


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