We are a healthcare company focused on breast health. We are developing a suite of tests and therapeutic medical devices, laboratory developed tests and services (LDT and/or invitro diagnostics) that address each of the four stages of the breast health care path: the cytological analysis of cells in nipple aspirate fluid (NAF), the cytological analysis of cells in ductal lavage fluid collected from each individual breast duct with manual breast duct microcatheters; the profiling of newly diagnosed breast cancers through the determination of gene expression profiles in formalin-fixed paraffin embedded breast cancer biopsy tissue; and the monitoring of breast cancer survivors for pre-clinical recurrence through a blood test for circulating tumor cells. We also have a therapeutic program to provide targeted, localized treatment of cancerous and pre-cancerous conditions through our patented microcatheters. All of our products and services are currently under development and are awaiting additional regulatory clearances prior to marketing and commercialization.
Our laboratory, the National Reference Laboratory for Breast Health, has been certified pursuant to the Clinical Laboratory Improvement Amendments, or CLIA. CLIA certification is legally required to receive reimbursement from federal or state medical benefit programs, like Medicare and Medicaid, and is a practical requirement for most third-party insurance benefit programs. Our CLIA-certified laboratory, which is permitted to accept samples from all 50 states under its CLIA certification, its state licenses, or, in New York under recognized exemption provisions while its license application is pending, examines the specimens by cytological analysis.
Atossa Genetics was founded in 2009 and is located in Seattle, Washington. The company is named for Atossa, the daughter of Cyrus the Great and the wife of Darius I, the King of the Achaemenid Empire. In about 470 BCE, Atossa became the first woman in recorded history to be diagnosed with breast cancer. While the disease has been with us for thousands of years, Atossa Genetics is committed to reducing its impact on women today and preventing it in the future.
Atossa Genetics’ management team comprises highly skilled individuals that work collaboratively to create value for patients, physicians, and the company’s shareholders. Together, the team has extensive expertise in business, finance, science, medicine, drug and healthcare product development, operations, and sales and marketing.