Atossa Genetics Receives Warning Letter From the Food and Drug Administration

  Atossa Genetics Receives Warning Letter From the Food and Drug
  Administration

Business Wire

SEATTLE -- February 25, 2013

Atossa Genetics, Inc. (NASDAQ: ATOS) (“Atossa” or the “Company”) received a
Warning Letter (“Letter”) from the FDA on February 21, 2013, regarding its
Mammary Aspirate Specimen Cytology Test (MASCT) System and MASCT System
Collection Test (together, the “System”). The Letter arises from certain FDA
findings during a July 2012 inspection, to which the Company responded in
August 2012, explaining why the Company believed it was in compliance with
applicable regulations and/or was implementing changes responsive to the
findings of the FDA inspection. The FDA alleges in the Letter that following
510(k) clearance the Company changed the System in a manner that requires
submission of an additional 510(k) notification to the FDA. Specifically, the
FDA observes that the Instructions For Use (IFU) in the original 510(k)
submission stated that the user must “Wash the collection membrane with
fixative solution into the collection vial…” and the current IFU states
“…apply one spray of Saccomanno’s Fixative to the collection membrane…” and
that “this change fixes the NAF specimen to the filter paper rather than
washing it into a collection vial.” At the time that the changes were made the
Company determined that a new 510(k) was not required in accordance with the
FDA’s guidance document entitled “Deciding When to Submit a 510(k) for a
Change to an Existing Device.”

The Letter also raises certain issues with respect to the Company’s marketing
of the System and the Company’s compliance with FDA Good Manufacturing
Practices (cGMP) regulations, among other matters.

The Company is committed to working with the FDA to resolve these issues in
the best interests of patients and their doctors. If the FDA does not agree
with the Company’s position concerning clearance of the System, Atossa may be
required to submit and receive clearance of a new 510(k) notice for the
current form of the System or revert to marketing the System using the prior
NAF processing method.

The Company has until March 14, 2013 to respond to the Letter and is currently
working to prepare that response. Among other things, the Company currently
expects that the response will explain why the Company believes that the
System in its current form has been and continues to be appropriately marketed
under a cleared 510(k) premarket notification, and why it is in substantial
compliance with applicable regulations, including cGMP.

Management notes that the FDA could direct other compliance-verification
activities or take other actions in connection with matters raised in the
Letter and in connection with other matters that the FDA could identify in the
future. Until these issues are resolved Atossa may be subject to additional
regulatory action by the FDA, and any such actions could disrupt the Company’s
ongoing business and operations.

About Atossa Genetics, Inc.

Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, is based in
Seattle, WA, and is focused on preventing breast cancer through the
commercialization of patented, FDA-cleared diagnostic medical devices and
patented, laboratory developed tests (LDT) that can detect precursors to
breast cancer up to eight years before mammography, and through research and
development that will permit it to commercialize treatments for pre-cancerous
lesions.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth
in this press release, including statements regarding Atossa’s plans,
regulatory actions, Atossa’s responses to regulatory actions, expectations,
projections, potential opportunities, goals and objectives are forward-looking
statements within the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. These forward-looking statements 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, regulatory
clearances, responses to regulatory matters, Atossa’s ability to continue to
manufacture and sell its products, the efficacy of Atossa’s products and
services, the market demand for and acceptance of Atossa’s products and
services and other risks detailed from time to time in the Atossa’s, filings
including its registration statement form S-1 filed January 28, 2013, as
amended and supplemented from time to time. All forward-looking statements are
qualified in their entirety by this cautionary statement, and Atossa
undertakes no obligation to revise or update any forward-looking statement to
reflect events or circumstances after the issuance of this press release.

Contact:

Atossa Genetics, Inc.
Steven C. Quay, M.D., Ph.D., FCAP
Chairman, President and CEO of Atossa Genetics and
Director of the National Reference Laboratory for Breast Health
800-351-3902
Steven.Quay@AtossaGenetics.com
or
Dian Griesel, Inc. (Investor Relations)
Dian Griesel and Susan Forman
212-825-3210
 
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