Atossa Genetics Seeks FDA Approval for Breast Health Tests

Atossa Genetics Inc. is not giving up on its ForeCYTE breast testing kit.

The Seattle, Wash.-based firm has submitted a premarket 510(k) notification with the U.S. Food and Drug Administration (FDA), seeking clearance of its ForeCYTE Breast Aspirator, breast pump and patient collection kit. The products are used to collect nipple aspirate fluid for laboratory cytological testing.

Under the Federal Food, Drug and Cosmetics Act, the FDA typically has 90 days to clear devices for commercial distribution, request additional information, or determine the product is not substantially equivalent to the predicate device. Sometimes, FDA’s review time takes longer.

The company plans to re-launch its ForeCYTE device once it receives FDA approval.

Atossa’s premarket notification occurs just months after the firm recalled its ForeCyte Breast Health Test and its Mammary Aspiration Specimen Cytology Tests from the market due to FDA concerns. “Atossa is removing the ForeCYTE Breast Health Test and MASCT device from the market to address concerns raised by the U.S. Food and Drug Administration in a warning letter received in February 2013,” the company said in a statement last fall. “The FDA raised concerns about (1) the current instructions for use (IFU); (2) certain promotional claims used to market these devices; and (3) the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF) specimen collection process identified in the current IFU. Atossa will remove existing product from the market until FDA’s concerns are addressed.”

Atossa Genetics develops breast health products and services; its wholly-owned subsidiary, The National Reference Laboratory for Breast Health Inc., provides laboratory services and tests.