Atossa Genetics: a focused pure play breast health testing company with huge potential to grow

By Grant Zeng, CFA

Atossa Genetics (NasdaqCM: ATOS ) is a medical diagnostics company focused on the prevention of breast cancer through the development and commercialization of diagnostic tests that can detect precursors to breast cancer , and through the research, development, and ultimate commercialization of treatments for pre-cancerous lesions.

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Atossa's diagnostic tests consist of patented medical devices cleared by the FDA that can collect fluid samples from the breast milk ducts (nipple aspirate fluid, NAF), where over 85% of breast cancers arise. These samples are processed at the Company's wholly-owned National Reference Laboratory for Breast Health , which has been certified pursuant to the Clinical Laboratory Improvement Amendments (CLIA), has been licensed in the states of California, Florida, Maryland, Rhode Island, and Washington, and is in the process of obtaining a license to accept testing samples from New York. 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.

Atossa's CLIA-certified laboratory examines the specimens by microscopy for the presence of normal, pre-malignant, or malignant changes as determined by cytopathology and biomarkers that distinguish "usual" ductal hyperplasia, a benign condition, from atypical ductal hyperplasia (ADH), which may lead to cancer. These cytopathological results provide patients and physicians with information about the care path that should be followed, depending on the individual risk of future cancer as determined by the results.

Additionally, Atossa is conducting research on the treatment of these pre-cancerous cells by using its patented and FDA-cleared microcatheters to deliver, directly into the milk ducts, pharmaceutical formulations that can be used to treat these pre-cancerous lesions. By using this localized delivery method, patients receive high local concentrations of these drugs at the site of the pre-cancerous lesions, potentially promoting efficacy of the treatment while limiting systemic exposure, which has the potential to lower the overall toxicity of these treatments.

Atossa is currently marketing two diagnostic tests and plans to offer two additional tests in early 2013.

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Atossa Genetics: a focused pure play breast health testing company with huge potential to grow - Analyst Blog

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