Advances in Bioscience and Biotechnology, 2013, 4, 846-852 ABB http://dx.doi.org/10.4236/abb.2013.48112 Published Online August 2013 (http://www.scirp.org/journal/abb/ ) A phase I safety and efficacy study of the mammary aspirate specimen cytology test device for collection of specimens for exfoliative cytopathology of the breast ducts * Shu-Chih Chen 1,2 , Stephen A. Vitkun 3 , Steven C. Quay 1,2# 1 Atossa Genetics, Inc., Seattle, USA 2 The National Reference Laboratory for Breast Health, Inc., Seattle, USA 3 Department of Anesthesiology, State University of New York at Stony Brook, Stony Brook, USA Email: # Steven.Quay@atossagenetics.com Received 19 June 2013; revised 20 July 2013; accepted 10 August 2013 Copyright © 2013 Shu-Chih Chen et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background: The ability to identify asymptomatic women at high risk for breast cancer using known pre-malignant changes in exfoliative cytopathology of nipple aspirate fluid is of clinical importance. Exfo- liative cytopathology of Nipple Aspirate Fluid (NAF) has been shown to be an important adjunct to the currently accepted standard of medical care, i.e. mammography, coupled with physical examination, for the diagnosis of breast cancer. This is especially important for the subset of women aged 18 - 50 who are not identified as “high risk”, and therefore, for whom mammography is not routinely recommended. The objective of this study was to determine if a new, patented Class II medical device, the Mammary As- pirate Specimen Cytology Test (MASCT) System, de- signed to collect NAF for subsequent cytological ex- amination is safe and effective. Methods: The MASCT medical device is a modified breast pump and was used to obtain bilateral specimens from 34 healthy, non-pregnant, female subjects for cytopathological examination. A conventional breast disease work-up was performed (medical history/risk factor collection, clinical breast examination and mammogram) and NAF specimens were collected. Specimen weight was measured and a cytopathological examination was performed. Vital signs measurements, clinical labora- tory analysis, and adverse event reporting were per- formed. Results: Based on cytopathological evalua- tion and/or measurable weight changes on the speci- men collection membrane filter, all breasts evaluated (100%) yielded nipple aspirate fluid. Specimen wei- ghts ranged from <1 to 37 mg and all specimens evaluated cytopathologically were deemed to be cli- nically useful. One patient’s specimen was not avail- able for cytopathological examination due to speci- men mishandling, resulting in 60 breasts (representing 30 subjects) being evaluated cytologically. Fifty-eight of sixty breasts evaluated cytopathologically (97%) were reported as cytology Class I, and 2 of 60 (3%) were reported as cytology Class IIa. Cytopathological findings correlated well with mammogram and clini- cal breast exam results. No adverse events, including pain from the collection procedure, were reported. Conclusion: Based on this clinical study, we conclude that the Mammary Aspiration Specimen Cytology Test device is safe and effective for the collection of mammary aspirate specimens for laboratory cytopa- thological testing. Keywords: Breast Cancer Risk; Atypical Hyperplasia; Exfoliative Cytopathology; Phase I Clinical Trial; Nipple Aspirate Fluid 1. INTRODUCTION Breast cancer is the most common cancer and a leading cause of cancer deaths among women in the United States. Two hundred thirty-two thousand women in the US are diagnosed each year with this disease. Preven- tion efforts are hindered by the fact that analysis of the tissue at risk traditionally requires a surgical biopsy. A non-operative method to evaluate women at high risk for breast cancer, women with known pre-malignant changes in their breasts, or to identify pre-malignant changes in asymptomatic women would be very beneficial. Mam- * Conflicts of interest: Shu-Chih Chen and Steven Quay are employees and have an equity interest in Atossa Genetics, Inc. Stephen Vitkun declares no conflicts of interest. # Corresponding author. OPEN ACCESS