A nipple fluid test is not an effective screening tool for breast cancer, U.S. regulators warned on Thursday, noting that mammography is the best way to detect the disease in its earliest, most treatable stages.
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.
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