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In the mid 1950s, Papanicolaou and Fleming first cytologically studied breast secretions (2, 3); since then, the literature on nipple aspirate fluid (NAF)  and breast secretions has expanded considerably (4).
The System has been FDA cleared for the collection of nipple aspirate fluid for cytological evaluation for the determination and/or differentiation of normal versus pre-malignant versus malignant cells.
1) Multiple long-term studies show that the identification of atypical epithelial cells found in cytology specimens, such as nipple aspirate fluid (NAF) or fine-needle aspiration (FNA), is also associated with an elevated risk of developing breast cancer, as was observed with open biopsies.
The licensed UND technology is based on detecting cancer biomarkers in breast nipple aspirate fluid (NAF) which is the platform used for the HALO[R] Breast Test marketed by Halo Healthcare for breast cancer risk assessment.
The presentation entitled, "Quantitative Galactose Oxidase Schiff's reaction in Nipple Aspirate Fluid may distinguish women with or without Breast Cancer" concluded by stating that "GOS reactivity as measured by adjusted chroma values are significantly different between normal patients, those with Ductal Carcenoma In Situ and those with invasive cancer" and that "these results warrant further investigation".
Multiple long-term studies show that the presence of atypical cells in nipple aspirate fluid (NAF) has been associated with an increased risk of developing breast cancer.
In the preface, the editor notes that this book, "is the first and nearly complete collection of applications of proteomics to analyze various human body fluids, including plasma, serum, urine, cerebrospinal fluid, pleural effusions, bronchoalveolar lavage fluid, sputum, nasal lavage fluid, saliva, pancreatic juice, bile, amniotic fluid, milk, nipple aspirate fluid, seminal fluid, vitreous fluid, dialysate, and ultra-filtrate yielded during renal replacement therapy.
In one study, ingestion of a soy protein isolate for 1 year stimulated nipple aspirate fluid volume in pre-menopausal women (Cancer Epidemiol.