On Feb 25, 2013, Atossa Genetics, Inc. (ATOS) received a Warning Letter from the FDA regarding its Mammary Aspirate Specimen Cytology Test (MASCT) System and MASCT System Collection Test.
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 Company is working with the FDA to resolve these issues in the best interests of patients and their doctors. 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.
We think the FDA letter won't impact Atossa's major business much based on our following analysis.
First, based on our conversation with the Company, we have reasons to believe that the new version of MASCAT System is in compliance with the FDA regulations and not required for 510(NYSE:K) clearance. In such a best scenario, the MASCAT System and The ForeCYTE Test will continue to operate as usual.
Second, if the FDA does not agree with the Company's position concerning clearance of the new version of the MASCAT System, Atossa may be required to submit and receive clearance of a new 510(k) notice for the current form of the System. Even in such a case, we think the business of ForeCYTE Test and the MASCAT System itself won't be much impact. Below are the reasons:
- Atossa's previous version of the MASCAT System has been approved by the FDA under 510(k). The Company can still use the old version of the System for NAF collection and processing and conduct the ForeCYTE Test.
- The difference between the old version and the new version of the System is not huge in our view. The old System washs the collection membrane with fixative solution into the collection vial. The new System only applies one spray of Saccomanno's Fixative to the collection membrane, and this change fixes the NAF specimen to the filter paper rather than washing it into a collection vial.
- Since the new version of the System is more convenient for patients and physicians, Atossa may resubmit the new System to the FDA for 510(k) clearance and at the same time use the old System for NAF collection and processing.
- If Atossa decides to resubmit the new System to the FDA for 510(k) clearance, it won't take a long time. Since the device is going to be filed as a new version of an already approved device, we estimate that time from submission to clear will be less than six months.
Therefore, we have a fair reason to believe that the FDA letter has only very limited impact on the Company's MASCAT System and the ForeCYTE Test business. We reminder investors that in addition to the ForeCYTE Test, Atossa has another test The ArgusCYTE Test on the market, and will launch two more tests in 2013. These three tests won't be impacted by the FDA requirement at all.
Based on our analysis, we think it is a great opportunity to accumulate Atossa shares if there is any correction after the FDA letter. We are firmly optimistic about Atossa's prospect as a pure play breast health testing company.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.