Nipple Test No Replacement for Mammogram

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According to the Food and Drug Administration (FDA), a nipple aspirate test should not displace the mammography imaging procedure or otherwise be used on its own to screen for 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. 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 alerted in a released statement.

The alert, which involved the National Association of Attorneys General, comes as a response against Atossa Genetics’ improper claims about its ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test.

“Those tests were voluntarily pulled from the market in October with a class I recall, which means that the product is dangerous or defective and has a reasonable chance of causing serious health problems or death,” the alert read.

Additionally, the only test mentioned in the alert that remains on the market was Halo Healthcare’s HALO Breast Pap Test.

The FDA said it will be keeping a close watch on this development and any other nipple aspriate test manufacturers with persistent observation of promotional activity.

Halo Healthcare's Website calls its nipple aspirate test an "early warning system" to exhibit 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 assessment, but is not a diagnostic test and will not replace the need to receive other clinical breast screenings, such as mammography.

Halo Healthcare has not had any direct contact with regulators on the issue other than standard reviews of labeling and materials, which haven’t led to citation for any violations, a company spokesperson said.Nipple-Aspirate

Yet, the FDA expressed that it, in accordance with the CDC, National Cancer Institute, American Cancer Society, and other organizations, “agree that mammography is the most effective method for detecting breast cancer in its earliest, most treatable stages.”

The latest National Comprehensive Cancer Network guidelines explicitly state that as ‘clinical utility of nipple aspiration is still being evaluated, it should not be used as a breast cancer screening technique.’

The FDA expressed concern that women and their physicians might believe the build up around such tests and skip mammograms, biopsy, or imaging all together.

On the other hand, "False positive results may lead to needless patient anxiety, along with unnecessary additional testing and treatment," the statement added.

"There was hope a number of years ago that you might be able to wash cells out of the milk ducts and find cancer that way," said director of breast imaging at Massachusetts General Hospital, Daniel Kopans, MD.

"Those of us in the field were skeptical, and it turns out our skepticism was correct."

Donald Berry, PhD, a biostatistician at the University of Texas MD Anderson Cancer Center who serves on the National Cancer Institute’s screening and prevention PDQ editorial board, did see a potential role for the test but only with suitable outlooks.

“It’s not a replacement for mammography,” he said in an interview at the San Antonio Breast Cancer Symposium.

'A finding of abnormal cells in the aspirate fluid raises the level of risk and might contribute to decisions about mammography for younger women. With the right kind of counseling it’s appropriate, but it’s not always possible to get the right kinds of counseling. It’s a dicey issue to be assessing somebody’s risk for two reasons: You don’t know what you’re going to do if somebody’s risk comes out one way or the other. And the other is what is it doing to the woman in terms of her quality of life and concern,” he said.


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