NEW YORK (GenomeWeb News) – Atossa Genetics today disclosed it has been warned by the US Food and Drug Administration over its system for the analysis of nipple aspirate fluid.
In a document filed with the US Securities and Exchange Commission, Atossa said that it received a warning letter from FDA regarding the system called Mammary Aspirate Specimen Cytology Test System, or MASCT, on Feb. 21.
FDA alleges in its warning that after MASCT was cleared by FDA, Atossa made changes to the platform that requires submission of an additional 510(k) notification, Atossa said
"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 [nipple aspirate fluid] specimen to the filter paper rather than washing it into a collection vial,'" Atossa said in its SEC document.
It added that when it made the changes to MASCT, it determined that based on FDA's guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device," not new submission was required.
The warning letter arises from FDA findings during an inspection during the summer. Atossa said that it responded in August to FDA and concerns that it had, providing reasons it believed it was in compliance with "applicable regulations and/or was implementing changes responsive to the findings of the FDA inspection."
Additionally, FDA has told the company that it has certain issues to the way Atossa markets the instrument as well as its compliance with FDA Good Manufacturing Practices regulation, and other matters.
Atossa is cooperating with FDA to resolve the issues, it said, but FDA may require it to submit and receive clearance of a new 10(k0 notice for the current iteration of MASCT, or the company may "revert to marketing the system using prior [nipple aspirate fluid] processing method."
The company has until March 14 to respond the FDA letter.
The MASCT system collects, ships, and analyzes nipple aspirate fluid, which contains cells and biomarkers that may be useful for the detection of breast cancer, as well as cellular changes that may portend breast cancer.
Seattle-based Atossa went public in November.
In afternoon trading on the Nasdaq, shares of Atossa were down 5 percent to $6.59.