SOURCE: Atossa Genetics, Inc.

Atossa Genetics, Inc.

September 08, 2015 08:00 ET

Atossa Genetics Receives Approval to Begin Clinical Study in Israel

Study to Evaluate Company's ForeCYTE Breast Aspirator Device Will Submit a Subset of Specimens From Carriers of the BRCA Germline Mutation to Contemporary Molecular Tests in Addition to Cytology; Overall Objective Is to Aid in BRCA Prognostication and the Consequent Timing of Surgery

SEATTLE, WA--(Marketwired - Sep 8, 2015) - Atossa Genetics (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 it has received institutional review board approval in Israel to begin a clinical study evaluating its ForeCYTE breast aspirator device.

The study will evaluate Atossa's ForeCYTE breast aspirator in the collection of Nipple Aspirate Fluid (NAF) in women aged 30-55.

Enrollment for the study will start in September 2015, and 70 women will be enrolled in three centers in Israel.

The study is the first outside the United States to use Atossa's ForeCYTE device; and it's also the first Atossa-sponsored study that will submit a subset of specimens (those from known carriers of the BRCA germline mutation) to contemporary molecular tests in addition to cytology (cellular evaluation of cells for evidence of ductal hyperplasia or atypia).

An important objective of the study is to characterize markers that can aid in the prognostication of women who are carriers of a BRCA germline mutation. BRCA carriers are known to have a 60%-80% lifetime risk of developing breast cancer, but, as yet, no markers are known that signal the transition from a healthy breast to a breast at imminent risk of presenting with cancer.

Specifically, the study is seeking to obtain data that will help in the development and validation of a molecular marker panel intended to help guide surgeons and women -- particularly the subset of participants who carry the BRCA germline mutation -- in the decision to consider prophylactic bilateral radical mastectomy.

Once validated in additional studies, it is believed that the molecular marker panel will ensure that prophylactic mastectomy in this high-risk group of women is never performed too late, never too early, and never unnecessarily, because 20%-40% of BRCA carriers will never develop breast cancer.

Additionally, the study is seeking to develop data to support a potential additional CE Mark for the ForeCYTE device in the EU.

"We're very pleased that this study can now get underway in Israel," says Dr. Steven Quay, Chairman, CEO & President of Atossa Genetics. "There's lots of potential knowledge to be gained here, and we believe that this will benefit all of our stakeholders, especially women at the highest known risk level for serious breast disease."

Additional information about the study can be found at: https://clinicaltrials.gov/ct2/show/NCT02539615?term=atossa&rank=1

About Atossa Genetics
Atossa Genetics Inc. is focused on improving breast health through the development of laboratory services, medical devices and therapeutics. The laboratory services are being developed by its subsidiary, The National Reference Laboratory for Breast Health, Inc. The laboratory 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 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, continue to manufacture and sell its products, recalls of products, the safety and efficacy of Atossa's products and services, performance of distributors, 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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