SOURCE: Atossa Genetics, Inc.
SEATTLE, WA--(Marketwire - Mar 5, 2012) - Atossa Genetics, Inc., a private healthcare company focused on the prevention of breast cancer through the 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, today announced certification from the U.S. Department of Health and Human Services' Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 for its breast health reference laboratory, the National Reference Laboratory for Breast Health. This certification follows a comprehensive inspection of its facilities, processes, and personnel, including review of the validation and clinical reports from its Laboratory Developed Tests (LDT) and the ForeCYTE Breast Health Test and ArgusCYTE Breast Health Test.
"Atossa Genetics has been dedicated to exceptional standards of operational performance from day one, and that commitment to quality was evident in our clinical laboratory certification process," said Shu-Chih Chen, Ph.D., Chief Scientific Officer, Atossa Genetics, and Supervisor, The National Reference Laboratory for Breast Health. "The objective of the CLIA program is to ensure quality laboratory testing and this certification is a critical step that follows the December 2011 launch of our two LDTs, the ForeCYTE and ArgusCYTE Breast Health Tests."
Atossa Genetics and The National Reference Laboratory for Breast Health, its wholly owned subsidiary, achieved CLIA-registration and California and Washington State licensing during 2011, enabling the Company to begin processing clinical samples from most states.
Mandated by the Code of Federal Regulations (CFR 42 Part 493.2), the CMS manage and conduct inspections of CLIA laboratories. The regulation was enacted to ensure consistent, accurate, and reliable clinical test results reporting from laboratories across the country used for the diagnosis, treatment, and/or prognosis of disease in human subjects. CLIA applies to all clinical laboratories operating in the U.S. and its territories and encompasses more than 200,000 clinical testing sites.
About Atossa Genetics, Inc.
Atossa Genetics, Inc. is a privately held health care company based in Seattle, Washington, 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-certified laboratory located in Seattle that provides comprehensive test results to guide personalized breast cancer prevention and treatment solutions.