SEATTLE, WA--(Marketwired - Aug 20, 2013) - Atossa Genetics, Inc. (NASDAQ: ATOS), the Breast Health Company, today announced the publication of a peer-reviewed paper titled "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." The article was published in Advances in Bioscience and Biotechnology, 2013, 4, 846-852 ABB doi:10.4236/abb.2013.48112 Published Online August 2013 (http://www.scirp.org/journal/abb/).

The single-center study, conducted by Dr. Stephen Vitkun, MD, State University of New York at Stony Brook, Stony Brook, NY, included 34 healthy, non-pregnant, female subjects, involved an evaluation of Atossa's patented Class II medical biopsy device, the Mammary Aspirate Specimen Cytology Test (MASCT) System, in a clinical setting for use in the collection of mammary aspirate specimens for laboratory exfoliative cytological testing. The objective of this study was to determine if the MASCT System is safe and effective.

The results demonstrate good patient and physician acceptance of the mammary aspiration technique and showed that based on this clinical study, the Mammary Aspirate Specimen Cytology Test is safe and effective for use in the collection of mammary aspirate specimens for laboratory cytopathological testing. The amount of time a physician or nurse would spend on the procedure was confirmed as approximately 15 minutes. There were no adverse events reported by the subjects and no safety observations of any kind. The collection process was not reported to be painful by any subject.

The cytopathology results showed that specimens were collected from 100 percent of subjects who participated in the study and that the specimens made available for cytopathologic examination were adequate for examination by the pathologist for classification.

Dr. Steven C. Quay, Chairman, CEO and President of Atossa Genetics, stated, "This clinical study demonstrates that the Mammary Aspirate Specimen Cytology Test is safe and effective for use in the collection of mammary aspirate specimens for laboratory cytological testing. We believe that all women, particularly women ages 18 to 50, including those with a family history of breast cancer, those with BRCA mutations and those with dense breasts, should use the MASCT System and should be tested as to their risk of breast cancer using the ForeCYTE Breast Health Test, which is provided by The National Reference Laboratory for Breast Health, Atossa's wholly-owned subsidiary."

About the MASCT SystemThe MASCT System is a patented, FDA designated Class II medical device for the collection of nipple aspirate fluid (NAF) for cytological evaluation. The collected fluid can be used in the determination and/or differentiation of normal versus pre-malignant versus malignant cells.

The MASCT System is a simple, safe and effective method for NAF collection. The MASCT System uses a hydrophilic ("water seeking") membrane in contact with the nipple to "wick" fluid from the orifice of the ducts by capillary action during the cycles of negative pressure, thereby increasing the frequency of obtaining NAF in women. The MASCT has been awarded 14 U.S. and international patents for aspects of this design.

NAF analysis performed at the National Reference Laboratory for Breast Health assesses a patient's breast health and can detect early cellular changes in the ducts. Regular assessment and tracking of cellular changes in the milk ducts, where most breast cancers begin, enables clinicians and patients to take control of breast health.

The MASCT System provides important benefits to both clinicians and patients.

About the ForeCYTE Breast Health Test

See the article here:
Atossa Genetics Announces Publication of Mammary Aspirate Specimen Cytology Test (MASCT) System Clinical Trial Results

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