Atossa Genetics has received certification from the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendment (CLIA) for its new national reference laboratory for breast health in Seattle.
Atossa Genetics also received a Medical Testing Site License from Washington State, No. C.FF.60228105.
The Seattle facility will offer Mammary Aspirate Specimen Cytology Test System ( MASCT), a diagnostic molecular profiling of nipple aspirate fluid to identify pre-cancerous cellular changes that may lead to breast cancer.
The MASCT System, a ‘Pap test for breast cancer’ is designed to collect nipple aspirate fluid (NAF), which contains cells from the lining of the milk ducts and the lobules where approximately 85% of all breast cancers originate.
Once collected, the NAF sample undergoes analysis in Atossa’s specially equipped pathology lab to determine whether the cells are normal, atypical (premalignant), or malignant.
The MASCT System is intended as an adjunct to mammography for women ages 40 to 75 and for younger women at high risk for breast cancer.
Atossa Genetics chairman and CEO Steven Quay said because NAF samples are among the smallest medical samples handled by clinical laboratories, specialized procedures, protocols, equipment and specially trained personnel are required to maximize the diagnostic value of each sample.