SEATTLE, WA--(Marketwired - Jul 1, 2015) - Atossa Genetics Inc. (NASDAQ: ATOS), the Breast Health Company, announced today that it has acquired a specimen bank from Dr. Susan Love Research Foundation containing approximately 25,000 ductal lavage specimens collected from approximately 1,000 patients every six months from 2004 to 2007. The specimen bank includes ductal lavage specimens collected at 16 centers in the United States and one in the United Kingdom and also includes blood and urine specimens, for a total of approximately 40,000 samples.
Dr. Steven Quay, Chairman, CEO & President of Atossa Genetics, said, "This specimen bank has tremendous potential value. It is possibly the largest specimen bank of its kind and because the specimens were collected up to 10 years ago with follow up on half of the participants, we may be able to assess if there is a correlation between the initial ductal lavage cytological findings or the presence of novel protein, RNA, and DNA biomarkers and the later development of breast cancer. Data that we generate should help inform the regulatory and clinical pathway for our FullCYTE ductal lavage device, which is currently under development."
The specimens were collected for a study initiated by Cytyc Corporation in 2004 called SEDE, or Serial Evaluation of Ductal Epithelium, to investigate the relationship between the production of nipple aspirate fluid, ductal lavage, and long-term breast health outcomes. The follow up was funded by a grant to Dr. Susan Love Research Foundation by the Avon Foundation for Women. Dr. Susan Love, Chief Visionary Officer of Dr. Susan Love Research Foundation commented, "Many women volunteered for this important study and I am very happy that Atossa Genetics will ensure that this resource will be utilized to bring us closer to predicting who is at risk for breast cancer so that it can be prevented."
About Atossa Genetics
Atossa Genetics Inc. is focused on improving breast health through the development of laboratory services, medical devices and therapeutics. The laboratory services are being developed by The National Reference Laboratory for Breast Health Inc. (the "NRLBH"). The laboratory services and the Company's medical devices are being developed so they can be used as companions to therapeutics to treat various breast health conditions. For more information, please visit www.atossagenetics.com.
Atossa's medical devices and the laboratory tests offered by the NRLBH must receive regulatory clearance and/or approval from the U.S. Food and Drug Administration ("FDA") in order to market ductal lavage for medical use, including breast cancer risk assessment. These products and any services related to them are not currently cleared or approved by the FDA for this or any other indication. The safety and effectiveness of the use of ductal lavage for breast cancer detection or risk assessment has not been established and has not been reviewed by the FDA.