A nipple aspirate test shouldn't take the place of mammography or otherwise be used on its own to screen for breast disease, the FDA warned.
'The FDA is not aware of any valid scientific data to show that a nipple aspirate test by itself is an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease,' the alert cautioned.
Manufactures have promoted these tests of fluid -- extracted with a pump rather than invasive sample collection -- as a stand-alone evaluation to screen and diagnose breast cancer, claiming they detect pre-cancerous abnormalities and diagnose breast cancer before mammography with just a sample of a few cells, the FDA said.
For example, Halo Healthcare's Website calls its nipple aspirate fluid test a 'Breast Pap Test' and an 'early warning system' to show abnormal cells 'years before they might turn into a cancerous lesion' and grow into tumors large enough to be seen on a mammogram.
A disclaimer cautions that HALO is FDA approved for the collection of nipple aspirate fluid for cytological evaluation but is not a diagnostic test and won't replace the need to undergo other clinical breast screening, like mammography.
However, the FDA expressed concern that women and their physicians might believe the hype and skip mammograms, biopsy, or imaging.
Alternatively, 'False positive results may lead to needless patient anxiety, along with unnecessary additional testing and treatment,' it added.
'There was hope a number a years ago that you might be able to wash cells out of the milk ducts and find cancer that way,' commented Daniel Kopans, MD, director of breast imaging at Massachusetts General Hospital.
'Those of us in the field were skeptical, and it turns out our skepticism was correct.'
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