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FDA: Nipple Test not Effective for Breast Cancer

Update Date: Dec 13, 2013 10:36 AM EST

Women who are high risk for breast cancer or are over the age of 40 are often recommended to get mammograms frequently. Despite the fact that mammograms could save lives by detecting cancer early on, having a mammogram is often described to be uncomfortable and painful. Due to the fact that people do not like to get mammograms, companies have attempted to find different screening methods that could ease the screening process. These companies have created a new method called the nipple aspirate test, which is being advertised as the new screening tool for breast cancer. Now, the U.S. Food and Drug Administration (FDA) has warned people that this nipple test is not approved by the agency and might not be an effective screening tool for breast cancer.

"FDA's concern is that the nipple aspirate test is being touted as a stand-alone tool to screen for and diagnose breast cancer as an alternative to mammography," David L. Lerner, MD, a FDA medical officer and specialist in breast imaging stated according to the FDA's news release. "Our fear is that women will forgo a mammogram and have this test instead."

According to the FDA, there is no evidence that the nipple aspirate test is an effective screening method. The test takes fluids from the nipples and examines the samples for any breast-related diseases.

Earlier this year in February, the FDA had given Atossa Genetics, Inc. a warning letter stating that the company has misbranded the test as a screening tool for breast cancer and other breast-related diseases. Atossa Genetics, Inc had started a voluntary recall of its ForeCYTE Breast Health Test in October.

"The cervical Pap smear has a known clinical benefit supported by extensive clinical studies over many years," FDA medical officer, Michael Cummings, MD commented in regards to Atossa's claim that its test was a 'Pap smear for breast cancer.' "[The Pap smear's] scientific ability to screen for cervical cancer is unquestioned."

The FDA stressed that getting a mammogram is still the most effective way of screening for breast cancer.

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