FDA Sends Warning Letter to Atossa Genetics, Inc.
Published: Feb 25, 2013
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. (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.
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.
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
Dian Griesel, Inc. (Investor Relations)
Dian Griesel and Susan Forman