ForeCYTE Breast Health Test Recall Issued Over FDA Concerns

Atossa Genetics Inc. has pulled two breast cancer screening products from the market due to concerns over the accuracy of the tests and a lack of federal approval.

The ForeCYTE Breast Health test recall was announced by the FDA on October 4, following a number of regulatory concerns, including the fact that the product was not cleared for sale to the public.

The FDA has expressed concerns that the products are being used as replacements for medical attention, and in many cases, necessary medical procedures.

Atossa is removing the products from the market until FDA concerns are addressed, but indicates that no side effects or adverse event reports have been reported as a result of any of the breast cancer screening tests.

The recall removed the ForeCYTE Breast Health Test and Mammary Aspiration Specimen Cytology Test (MASCT), including the MASCT system kit, Clarify System Kits, Nipple Aspirate Fluid Laboratory Kit, and all Patient Sample Kits, completely from the U.S. market. A full list of part numbers and product codes is available in the recall notice, linked above. All lot numbers are affected.

According to Atossa, approximately 90% of the inventory is still with the distributors. The remaining portion of the products are in customer hands.

Devices Not Cleared By FDA

The FDA approved the MASCT as a sample collection device, but the MASCT has not been cleared as a tool to use in the screening or diagnosis of breast cancer. The ForeCYTE has not been cleared or approved by the FDA for any use.

The FDA also warns that neither product should be used as a replacement for a mammogram, diagnostic imaging tests or biopsies conducted by healthcare professionals.

The ForeCYTE is marketed by Atossa as a non-invasive biopsy for early detection of pre-cancerous cells in the breast. It is a breast pump which collects nipple aspirate fluid (NAF), which is sent to a laboratory to be tested for abnormal cell growth.

The MASCT is a device used in the collection of the nipple aspirate fluid to be evaluated for normal versus pre-malignant versus malignant cells.

The recall stems from a warning letter issued by the FDA to Atossa in February, which outlines observations made following visits to the Atossa manufacturing plant during July 2012.

In the letter, federal regulators warn the “devices [are] intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.”

The FDA detailed recommendations made to Atossa concerning failure to maintain procedures to control the design of the devices, promotional claims concerning cancer detection used to market the product, along with a need for clearance from the FDA for changes to the NAF specimen collection process.

Concerns have also been expressed by federal health regulators that the products may produce both false positives and false negative results. Incorrect results which can lead patients against consulting with their doctor or seeking medical attention from other healthcare professionals.

In response to the FDA’s concerns, Atossa issued the recall and will continue to keep it in effect until all issues have been resolved. The FDA emphasizes patients follow all recommendations of their doctors about breast cancer screening and diagnosis.

Distributors and customers are warned to stop using the products immediately and call Atossa at (800) 351-3902 for instructions on how to return the kits. Customers can also call (888) 219-4629 with further questions.