NEW YORK (GenomeWeb News) – Breast cancer diagnostics developer Atossa Genetics said today that its breast health reference lab has received Clinical Laboratory Improvement Amendments certification from the Centers for Medicare and Medicaid Services.
The company's National Reference Laboratory for Breast Health subsidiary, located in Seattle, was certified after an inspection of its facilities, processes, and personnel, and a review of the validation and clinical reports from its lab-developed tests, and the ForeCyte and ArgusCyte Breast Health Tests.
The company's tests use molecular and cellular biomarkers for breast cancer risk, and are based on its Mammary Aspirate Specimen Cytology system, which enables nurses or physician assistants to collect samples in around 10 minutes.