Atossa Genetics, Inc. Announces Licensing of Its New National Reference Laboratory for Breast Health

May 24, 2011 |

2 min read

SEATTLE, WA--(Marketwire - May 24, 2011) -

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Atossa Genetics, Inc., a privately-held health care company focused on the development and marketing of novel cellular and molecular diagnostic risk assessment products and services for breast cancer, announced today receipt of a Certificate of Registration, No. 50D2024381, from the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendment (CLIA), for its new laboratory facility in Seattle, Washington. Concurrently, the Company received a Medical Testing Site License from Washington State, No. C.FF.60228105.

“We are very pleased to have been granted the CLIA License and the Washington State Medical Testing Site License for our new National Reference Laboratory for Breast Health. These are critical steps forward as we prepare to manufacture and launch the Mammary Aspirate Specimen Cytology Test System this year,” stated Steven C. Quay, M.D., Ph.D., FCAP, Chairman and Chief Executive Officer of Atossa Genetics. “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.”

The Company anticipates that it will use both conventional cytology and advanced molecular diagnostic technologies in its laboratory and engage a staff of professional medical personnel to deliver accurate and comprehensive diagnostic reports.

The new National Reference Laboratory for Breast Health is located in the Seattle Life Sciences Building at 1124 Columbia Street, Seattle, Washington 98104.

About the Mammary Aspirate Specimen Cytology Test System

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 will undergo analysis in Atossa’s specially equipped pathology lab to determine whether the cells are normal, atypical (premalignant), or malignant. The MASCT System uses no radiation, is simple, painless, and inexpensive, and takes less than 5 minutes in a doctor’s office or mammography center. 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.

The MASCT System is expected to be launched in the Pacific Northwest this year and across the U.S. in 2012.

About Atossa Genetics, Inc.

Atossa Genetics, Inc. is a privately-held health care company dedicated to improving breast health by commercializing the Mammary Aspirate Specimen Cytology Test System (MASCT System) and second-generation products in development. Patients, health care providers, investors and others seeking information on the MASCT System or the latest information and research on breast cancer risk assessment, diagnostics, prevention, and treatment options, should visit www.atossagenetics.com.