MASCT System Clinical Testing

A clinical trial of the MASCT System was performed at the State University of New York, Stony Brook, NY to test the efficiency of NAF collection in normal volunteer women. Thirty-one healthy, non-pregnant, pre-menopausal female subjects were tested with the MASCT System device for the ability to collect NAF samples for cytological examination, using the NAF cytology classification system of the College of American Pathologists.

Of the 31 subjects, 30 (97%) had measurable NAF; 24 bilaterally and 6 unilaterally. NAF samples ranged from 1 to 37 µL with an average of 7 µL and all samples collected were deemed to be clinically useful. Fifty-eight of sixty NAF samples were reported as cytology Class I, and 2 of 60 were reported as cytology Class IIa. No adverse events were reported. The FDA, based on a 510(k) filing that included this clinical data and other data, provided a Premarket Notification that this class II device “is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.”