FDA Warning on Nipple Aspirate Test as Breast Cancer Screen

Zosia Chustecka


December 13, 2013

The US Food and Drug Administration (FDA) has issued a warning about nipple aspirate tests, which are pump devices that collect fluid from a woman's breast and then analyze the fluid to see if it contains any abnormal cells.

The FDA says that a nipple aspirate test is not an effective screening tool for breast cancer or other breast disease. It is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for and diagnose breast cancer.

"Certain manufactures are promoting the use of nipple aspirate tests as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming they are an alternative to biopsy or mammography. They also claim that a nipple aspirate test can detect precancerous abnormalities and diagnose breast cancer before mammography with just a sample of a few cells," the agency notes.

The FDA "is concerned that women will believe these misleading claims about a nipple aspirate test and not get mammograms and/or other needed breast imaging tests or biopsies."

In addition, the agency warns that nipple aspirate tests could lead to potential harm by issuing false-negative results, indicating the absence of breast cancer when cancer exists, and false-positive test results, indicating the presence of breast cancer when none exists. False-negative results may lead to delayed diagnosis and/or delayed treatment of breast cancer, with increased risk for serious illness or death. False-positive results may lead to needless patient anxiety, along with unnecessary additional testing and treatment.

The National Comprehensive Cancer Network 2013 guidelines state that the clinical utility of nipple aspiration is still being evaluated and it should not be used as a breast cancer screening technique, the FDA adds.

Voluntary Recall of Atossa Genetics' ForeCYTE Test

Although the FDA does not name any test or manufacturer in its press release, the wording in the public warning, released on December 12, is similar to that in a warning letter that was sent to Atossa Genetics earlier this year. Atossa describes itself as "The Breast Health Company," and has been marketing the ForeCYTE nipple aspirate test.

The company had an exhibition stand promoting this test at this year's annual meeting of the American Society of Clinical Oncology and, in a May press release, the company claimed that the ForeCYTE Breast Health Test "detects reversible precancerous conditions in the breast up to 8 years before they become cancer."

"We believe that our ForeCYTE Breast Health Test represents a breakthrough in breast cancer risk assessment testing," commented Chris Destro, vice president of Atossa, at the time. "The ForeCYTE test can provide vital early detection of cancer or precancerous conditions and therefore help prevent breast cancer and save lives."

However, it now emerges that the company had already been warned about making such claims by the FDA in a letter it had received in February.

The company mentioned this letter when it initiated a voluntary recall in October to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. This voluntary recall also included the MASCT System Kit and Patient Sample Kit.

Atossa said it was removing the products from the market "to address concerns" raised by the FDA in a warning letter received by the company in February.

The FDA had raised concerns about the current instructions for use (IFU), certain promotional claims used to market these devices, and the need for FDA clearance for certain changes made to the nipple aspirate fluid specimen collection process identified in the current IFU.

The company explained that the MASCT device has been cleared by the FDA for use as a sample collection device, with the provision that the fluid collected using this device can be used to determine and/or differentiate between normal, precancerous, and cancerous cells. However, it added, the MASCT device has not been cleared by the FDA for the screening or diagnosis of breast cancer.

In addition, the ForeCYTE Breast Health Test has not been cleared or approved by the FDA for any indication, the company noted.

In the press release about its voluntary recall, the company noted that the ForeCYTE Breast Health Test and the MASCT device are not a replacement for screening mammograms, diagnostic imaging tests, or biopsies. "Patients should follow the recommendations and instructions of their physician with respect to breast cancer screening and diagnosis," it commented.

"To date, Atossa is unaware of any adverse incidents or injuries associated with the use of the ForeCYTE Breast Health Test and the MASCT device or the processing method currently identified in the IFU. Additionally, Atossa is unaware of any risk to health or injury for clinicians or the patient population that have used these devices," the company said.

"However, these devices may produce false-positive or false-negative results. Although not cleared or intended for this use, if these devices are used as a substitute for recommended screening or diagnosis of breast cancer, FDA is concerned that patients may choose to forgo recommended mammograms and necessary biopsies," it added.

It now appears that the company is planning to obtain FDA approval for the test. In its latest press release, the company noted that it met with the FDA on November 4 to discuss the regulatory pathway and data requirements to support Atossa's planned 510(k) Premarket Notification submission for the ForeCYTE breast pump and patient kit. Atossa reported that "the meeting was productive and will help inform the strategy, content, and timing of the regulatory requirements for the medical device."


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