FDA Warns Against Usage Of Nipple Aspirate Test

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Some women who are put off by the idea of going in for mammograms on a regular basis may opt for the type of test that they can carry out on their own in their own home.  However, in a new consumer health update, the Food and Drug Administration warns that there could be some fairly big drawbacks to this type of test.

The test is known as a nipple aspirate, and it works by way of screening for cells in the fluid from the nipple to determine if those cells could be cancerous.  Marketing for the product, which hails from Atossa Genetics, claims that the test acts as a Pap smear that can help determine susceptibility to breast cancer.

The FDA takes issue with many of the claims being touted by the company, the Pap smear language among them.  One representative of the agency points out that the company has produced no evidence to support the efficacy of the device as a Pap smear, especially since it’s not currently possible to determine if abnormal breast cells have a greater likelihood of becoming cancerous.  The FDA is also very concerned about the possibility of the test producing false results, especially those that could lead a user to fail to seek prompt treatment when necessary.

The products were taken off the market as part of a recall action that resulted from the FDA’s efforts to warn the company about the risks of their product.  Owners should understand this and seek a mammogram instead of relying on the potentially faulty item.