SEATTLE, WA--(Marketwire - December 06, 2011) - Atossa Genetics, Inc.
, a health care company developing and commercializing a comprehensive set of innovative, proprietary breast health evaluation products and services, today announced the first phase of the commercialization of its new, FDA-cleared ForeCYTE Breast Health Test
(SM). This new test is initially available under a Field Experience Program for select customers in the U.S. A national roll out of the test is planned for 2012.
The ForeCYTE Breast Health Test(SM) has been cleared by the U.S. Food and Drug Administration (FDA) for use in women. The FDA-cleared indication for use states that the collected Nipple Aspirate Fluid (NAF) "can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells." The ForeCYTE Breast Health Test(SM) is intended as an adjunct to mammography for women ages 50 to 75 and for younger women ages 20 to 49 for whom screening mammography is not recommended. The ForeCYTE Breast Health Test(SM) uses no radiation, is simple and painless, and takes approximately 5 minutes per breast in a doctor's office or mammography center.
"Breast cancer typically arises over an approximately eight-year period during which cells lining the milk ducts or lobules of the breast undergo a series of changes from normal to atypical to malignant," stated Steven C. Quay, M.D., Ph.D., FCAP, President and CEO of Atossa Genetics. "Patients whose cells are undergoing the morphologically identifiable stages of mild hyperplasia, moderate hyperplasia, and atypical ductal hyperplasia are at significantly higher risk for breast cancer over the ensuing two-year period. By identifying women at higher risk for breast cancer due to abnormal breast cytology and other risk factors, we empower doctors and their patients with information that is accurate and actionable for personalized breast cancer prevention and breast health."
Dr. Quay continued, "The ForeCYTE Breast Health Test(SM) integrates genetic and family history with both traditional cytology and molecular subtyping to provide a personalized risk assessment. On average, the likelihood of a woman with a normal ForeCYTE Breast Health Test(SM) being diagnosed with breast cancer in the following two-year period is 0.3%."
About the ForeCYTE Breast Health Test(SM)
The ForeCYTE Breast Health Test(SM) is designed to collect nipple aspirate fluid (NAF), which contains cells from the lining of the milk ducts and lobules of the breast, where approximately 99% of all breast cancers originate. Once collected through a quick, simple, painless, non-invasive procedure, the NAF samples are sent for analysis to Atossa's specially equipped, CLIA-registered pathology laboratory, the National Reference Laboratory for Breast Health, to determine whether the cells are normal, atypical or malignant, using a patented, multiplex, immunohistochemical procedure. A detailed report based on the laboratory analysis of NAF and other risk factors is then generated. The information contained in the report is actionable for personalized cancer prevention and breast health. For additional information on the ForeCYTE Breast Health Test(SM), please visit http://nrlbh.com/testing-services/risk-assessment.php or call or 800-351-3902.
About Atossa Genetics, Inc.
Atossa Genetics, Inc. is a privately held health care company that provides a comprehensive set of innovative breast health evaluation products and services that provide accurate and actionable results for personalized cancer prevention and breast health. Atossa has established the National Reference Laboratory for Breast Health, a specially equipped, CLIA-registered laboratory located in Seattle, Washington, that provides comprehensive test results to guide personalized breast cancer prevention and treatment solutions. Patients, health care providers, investors and others seeking information on Atossa and its products and services should visit www.atossagenetics.com.