SOURCE: Atossa Genetics, Inc.

Atossa Genetics, Inc.

September 25, 2015 08:00 ET

Atossa Genetics' Laboratory Receives ISO 15189:2012 Certification

SEATTLE, WA--(Marketwired - Sep 25, 2015) - Atossa Genetics Inc. (NASDAQ: ATOS), a healthcare company focused on improving breast health through the development of pharmaceuticals to treat breast health conditions and through commercialization of medical devices and laboratory tests, today announced that its laboratory, The National Reference Laboratory for Breast Health, Inc. (the NRLBH) has received certification under ISO 15189:2012. The NRLBH is located in Seattle, Washington and provides pharmacogenomics testing as well as cytology testing of nipple aspirate fluid.

The International Organization for Standardization (ISO) is an independent, non-governmental membership organization and the world's largest developer of voluntary international standards. ISO 15189 includes provisions for advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab's role in the education and training of health care staff. As such, ISO 15189:2012 specifies the requirements for quality and competence in medical laboratories. It is used to confirm the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies. ISO 15189:2012 is among the most rigorous regulatory standards that any laboratory can achieve. 

Atossa's laboratory is also certified by the Centers for Medicare and Medicaid Services' Clinical Laboratory Improvements Amendment (CLIA), and accredited by the College of American Pathologists (CAP) which is the highest level of laboratory accreditation.

"ISO 15189:2012 further demonstrates our commitment to excellence and the doctors and patients served by our laboratory," said Dr. Steven Quay, Chairman, CEO & President of Atossa Genetics. "Achieving ISO certification together with certifications under CLIA and CAP place our lab in the upper echelon of the highest quality laboratories in the country," he continued.

About Atossa Genetics

Atossa Genetics Inc. is focused on improving breast health through the development of therapeutics, medical devices and laboratory services. The laboratory services are being developed by its subsidiary, The National Reference Laboratory for Breast Health, Inc. The laboratory's services and the Company's medical devices are being developed so they can be used as companions to therapeutics to treat various breast health conditions. For more information, please visit www.atossagenetics.com.

Forward-Looking Statements

Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa to sell its products, responses to regulatory matters, Atossa's ability to achieve its objectives and continue to manufacture and sell its products, recalls of products, the safety and efficacy of Atossa's products and services, performance of distributors and investigators, whether Atossa can launch in the United States and foreign markets the additional tests, devices and therapeutics in its pipeline in a timely and cost effective manner, and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

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