Nipple test not an effective breast cancer screening tool, FDA warns

12/12/2013

Breast cancer screening by nipple fluid test is not as effective as mammography, which leads to earlier diagnosis & improves treatment odds, according to US regulators.

The Food and Drug Administration, in a statement to healthcare professionals, said it is concerned that women will believe misleading claims about a nipple aspirate test and not get mammograms or other needed breast imaging tests or biopsies.

The agency noted that it had issued a warning letter earlier this year to Atossa Genetics Inc about its nipple aspirate fluid collection device and process. The company recalled the product in October.

The FDA said it is not aware of any valid scientific data to show that nipple aspirate testing by itself is an effective screening tool for any medical condition.

 

Source: Reuters: http://www.reuters.com/article/2013/12/12/us-cancer-breast-mammogram-idUSBRE9BB15R20131212

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