MASSDEVICE ON CALL — The FDA cautioned women last week not to use nipple aspirate tests as a replacement for mammograms or other tests for breast cancer.
The federal watchdog agency said the aspirate tests, which draw fluid from the breast through the nipple, "an determine whether the fluid collected from the breast contains any abnormal cells."
But the aspirate tests haven’t been proven to be effective in turning up evidence of breast cancer or other ailments, the FDA said.
"The FDA is alerting the public, including women and health care providers, that a nipple aspirate test is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer. 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," according to the alert. "Certain manufactures are promoting the use of nipple aspirate tests as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming they are an alternative to biopsy or mammography. They also claim that a nipple aspirate test can detect pre-cancerous abnormalities and diagnose breast cancer before mammography with just a sample of a few cells. The FDA is concerned that women will believe these misleading claims about a nipple aspirate test and not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious adverse health consequences."
The FDA called out Atossa Genetics Inc.’s Mammary Aspiration Specimen Cytology Test (MASCT), ForeCYTE Breast Health Test systems and the HALO Breast Pap Test as "not a substitute for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself for breast cancer screening or diagnosis," according to the alert.
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