SOURCE: Atossa Genetics, Inc.

Atossa Genetics, Inc.

August 20, 2013 08:30 ET

Atossa Genetics Announces Publication of Mammary Aspirate Specimen Cytology Test (MASCT) System Clinical Trial Results

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 System
The 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

The ForeCYTE Breast Health Test, available from the National Reference Laboratory for Breast Health (NRLBH), is intended for the 110 million women in the U.S. ages 18 to 73. It uses NAF collected by the MASCT System in a painless, quick and non-invasive procedure that can be done in a physician's office. The ForeCYTE Test provided by the NRLBH can provide vital early detection of cancer or pre-cancerous conditions that may progress to cancer over an approximately eight-year period and before cancer can be detected by mammography or other means and without the risks of radiation, especially in women younger than age 50. No invasive biopsy needles or open surgical incisions are used in the ForeCYTE Test.

Just as the Pap smear has reduced cervical cancer rates by over 70 percent, becoming the most successful screening test in medicine, the goal of the NRLBH is to reduce the stubbornly high rate of breast cancer through the early detection of the precursor changes that can lead to breast cancer and the treatment of those early changes.

About Atossa Genetics, Inc. and the NRLBH

Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, based in Seattle, WA, is focused on preventing breast cancer through the commercialization of patented, FDA-designated Class II diagnostic medical devices and, through its wholly-owned subsidiary, the NRLBH, patented, laboratory developed tests (LDT) that can detect precursors to breast cancer up to eight years before mammography.

The NRLBH is a CLIA-certified high-complexity molecular diagnostic laboratory located in Seattle, Washington.

For additional information on Atossa, please visit www.atossagenetics.com. For additional information on the ForeCYTE Breast Health Test and the NRLBH, please visit www.nrlbh.com.

Forward-Looking Statements

Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with clinical trial results, actions by the FDA, regulatory clearances, responses to regulatory matters, Atossa's ability to continue to manufacture and sell its products, the efficacy of Atossa's products and services, the market demand for and acceptance of Atossa's products and services, performance of distributors and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time. 

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