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FDA Warns Against Test Touted As Mammogram Alternative

Mammograms are no woman's idea of fun, but if someone suggests that you could skip that aggravation just by vacuuming a little bit of fluid from the breast, think again.

Nipple aspirate tests being offered in doctors' offices are no substitute for mammograms, the Food and Drug Administration said Thursday.

Several companies have been marketing nipple aspirate tests, which use a device similar to a breast pump, as a "breast Pap test."

There's just one problem with that pitch. And it's a big one. There's no evidence that looking for abnormal cells in the fluid from milk ducts is any good at screening for cancer, unlike the Pap test, which has long been the standard in cervical cancer screening.

"Did they ever do studies to assess cancer risk using the nipple aspirator? No," says Dr. Tarik Elsheikh, medical director for anatomical pathology at the Cleveland Clinic. "It has nothing to do with evaluating cancer risk in women."

Indeed, the FDA had approved the devices only as being safe for extracting breast fluid. But the fact that these tests are being sold to women and their doctors for cancer screening says a lot about the state of medical marketing these days.

We called up Elsheikh because he had reviewed the research on nipple aspirate tests in 2009. And frankly, we wanted to find out why a pathologist with his academic cred was writing about them.

Gynecologists and primary care doctors he knew had started asking him if they should buy the machines for their practices, Elsheikh says. The sales reps were saying it was a procedure that women would have each year. The test takes five minutes, costs about $100, and is not covered by insurance. "They're convincing these docs that they can make a lot of money," Elsheikh says. "They're finding an audience, unfortunately."

The idea of looking for cancer in breast fluid isn't completely unfounded. No less an authority than George Papanicolaou, the inventor of the Pap test, suggested back in the 1950s that changes in the cells in breast fluid might be used to predict a woman's cancer risk.

But no one has yet come up with a way to do that, especially in women who don't already have a higher risk of cancer.

One problem with using breast fluid as a screening tool is that breasts often don't produce fluid. The machine sold by Halo Healthcare, of Irvine, Calif., manages to extract fluid just half the time, according to the company's website. And only 1 percent of women have atypical cells in that fluid, the company notes.

Finding atypical cells doesn't mean a woman has cancer, or even has higher risk. In 2103, guidelines from the National Comprehensive Cancer Network stated that nipple aspiration is still being evaluated and should not be used for breast cancer screening. "It could have potential as a research tool," Elsheikh says. "I don't think it's ready for clinical practice."

In September, the FDA issued a Class I recall of nipple aspirate tests sold by Atossa Genetics of Seattle, saying that they could cause "serious adverse health consequences or death," including false alarms for breast cancer when none exists, and false assurances that could lead a woman to avoid treatment.

A spokeswoman for Halo Healthcare, which was mentioned in the FDA statement but whose product was not recalled, told Shots that its test wasn't meant to exclude mammogram or biopsy. "We were surprised when we saw what the FDA issued yesterday," Arlene Bumb says, "I think we've been very diligent in saying that in our literature."

In its warning, the FDA says that mammograms, imperfect as they are in finding cancer early, remain the best way to screen for breast cancer.

Women who have had a nipple aspirate test for breast cancer screening should have a mammogram according to current guidelines, the agency added.

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