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. Exfoliative 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 Aspirate
Specimen Cytology Test (MASCT) System, designed to collect NAF for subsequent
cytological examination 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 collected. Specimen weight was measured and a cytopathological examination was performed. Vital signs
measurements, clinical laboratory analysis, and adverse event reporting were performed. Results: Based on
cytopathological evaluation and/or measurable weight changes on the specimen collection membrane filter, all breasts evaluated (100%) yielded nipple aspirate
fluid. Specimen weights ranged from <1 to 37 mg and all specimens evaluated
cytopathologically were deemed to be clinically useful. One patient’s
specimen was not available for cytopathological examination due to specimen
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 clinical 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 cytopatho-logical testing.