The HALO Breast Pap Test

A breast cancer screening test that lets you avoid the pain of a yearly mammogram sounds great—but the U.S. Food and Drug Administration (FDA) and researchers say the HALO Breast Pap test isn't the right alternative. It's no longer on the market after the FDA issued serious warnings about the ramifications of relying on this type of technology for breast cancer diagnosis.

The test itself was considered safe; however, if it makes women think they can skip their annual mammograms, it could mean cancer is diagnosed later than it could've been.

How It Worked

The test used aspirators to withdraw breast fluid from the nipples. It took about five minutes and used warmth and suction, and many women compared it to the feeling of a breast pump.

The extracted fluid could then be tested for abnormal cells.

Controversy

When Halo Healthcare, Inc. began selling the HALO Breast Pap test device, which was manufactured by NeoMatrix, LLC, it was marketed as a possible means of determining a woman's risk of developing breast cancer, not as a diagnostic tool.

However, a 2009 review published in Diagnostic Cytopathology described a marketing campaign aimed at doctors that encouraged them to use this test on all women during annual exams, claiming that it could detect breast cancer up to 10 years before a mammogram. The review stated, "there is no data available regarding this new system, outside rare reports sponsored by the manufacturer."

Speculation that cancer cells may show up in breast fluids well before a tumor is detectable, or that stray cancer cells may be an indicator of cancer risk dates back to the 1950s. Thus far, though, no research has conclusively proven this. That is, the presence of abnormal cells does not always mean breast cancer is present.

The FDA approved the HALO device in 2005. However, when it comes to medical devices, FDA approval only means that something is safe to use—it doesn't have to be proven effective to get the initial green light.

FDA Action

In February of 2013, the FDA issued a warning letter to Atossa Genetics, Inc., which marketed a similar test. The warning letter stated the company was using false or misleading labeling to sell its nipple aspirate test. The agency says the manufacturer had claimed its test was "literally a Pap smear for breast cancer," comparing it to the proven use of the Pap smear as a screening test for cervical cancer.

Later that year, the FDA issued a Class I recall of the tests, saying they had been "falsely described as alternatives to mammograms" and therefore "could result in serious health consequences if breast cancer goes undetected."

It said the nipple aspirate test may:

• Produce false positives
• Produce false negatives
• Miss cancerous tumors
• Provide false reassurance

The agency also stated that it was unaware of any valid scientific data to show that the test or anything like it, on its own, was an effective screening tool for any medical conditions.

A Word From Verywell

In its 2013 statement, the FDA said it was unaware of any HALO tests still on the market. However, that doesn't mean they're all out of use. If you should come across anyone marketing or using this test, you're better off skipping it and sticking to tests that have scientific backing—breast self-exams, genetic testing, and a yearly mammogram after age 40.