NEW YORK (GenomeWeb News) – Atossa Genetics on Friday voluntarily recalled its ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology (MASCT) Test device from the market in the wake of concerns raised by the US Food and Drug Administration.
The recall includes the MASCT System Kit and the Patient Sample Kit, the Seattle-based firm said, adding that distributors and customers should stop using the products and return them to the company immediately.
The recall follows a warning letter from the FDA to Atossa in February, in which the agency raised concerns about the current instructions for use; certain promotional claims made by Atossa in its marketing of the devices; and the need for FDA clearance for changes that the company made to the nipple aspirate fluid specimen collection process identified in the current instructions for use.
While the MASCT device was cleared by FDA for use as a sample collection device — provided that the fluid being collected can be used to determine and/or differentiate between normal, precancerous, and cancerous cells — the device was not cleared as a screening or diagnostic test for breast cancer, Atossa said. Additionally, the ForeCYTE test is not cleared or approved by FDA for any indication.
Neither the ForeCYTE test nor MASCT device are a replacement for screening mammograms, diagnostic imaging tests, or biopsies, Atossa said.
On a conference call on Friday, Atossa Chairman and CEO Steven Quay said that the company believes the MASCT System is a Class II medical device, which requires FDA clearance for marketing in the US. It also believes, however, that the processing of the nipple aspirate fluid specimen in Atossa's CLIA laboratory is regulated under CLIA regulations as a laboratory developed test.
"However, based on recent input from the FDA and our professional advisors, we understand that the processing of the nipple aspirate fluid specimens can be viewed as a Class II in vitro diagnostic service that requires premarket notification before commercialization in the United States," Quay said. "FDA has informed us that it takes that position."
As a result, the company decided to issue its voluntary recall.
Atossa plans to file a new 510(k) submission to FDA "that covers the collection, preparation, and processing of nipple aspirate fluid specimen," that supersedes an earlier 510(k) submission that the company withdrew, Quay said.
The firm expected to make the new submission by the end of October, but because of the current government shutdown, the timing of submission is "impossible to predict," said Quay.
The company is currently assessing the likely cost impact resulting from the recall, Quay said.
Atossa is not aware of any adverse incidents or injuries resulting from use of the ForeCYTE test and the MASCT device or the processing method currently identified in the instructions for use. It also is not aware of any health risk or injury for clinicians or the patient population that have used the devices.
But, Atossa said, the devices may provide false positive or false negative results, and FDA is concerned that if used for screening or diagnostic purposes in breast cancer, patients may choose not to undergo recommended mammograms or necessary biopsies.
Atossa is removing all existing products from the market until FDA's concerns are addressed. About 90 percent of the affected products are currently in inventory with Atossa's distributors, while the remaining quantities are at customer sites in the US, it said.
In Monday morning trade on the Nsdaq, shares of Atossa plummeted 47 percent to $2.80.