The Halo system, a procedure whose results can be used to assess risk for breast cancer, was approved by the FDA in 2005. It was introduced to a wide national audience on Sept. 2 of last year, when Dr. Lisa Masterson, a California ob/gyn, spoke about it on Rachael Ray’s daytime talk show.
Yes, THAT Rachael Ray. The “eat your way around the country on $40 a day” Rachael Ray. The girl-next-door you see chopping onions madly for her “30 Minute Meals” on the Food Network.
What’s up with that strange confluence of topics?
Well, apparently Rachael’s daytime talk show goes well beyond the bounds of brownies and bouillabaise, since she’s now ranging into nipple fluid. And thanks to her show, viewed by millions of women, there’s been increased buzz around Halo, a nipple-fluid collection system developed and marketed by California company NeoMatrix.
And the Halo system is…?
…a safe, painless, fast and easy way to collect nipple fluid, fluid from the milk ducts in a woman’s breast. It uses heat, mild compression, and gentle suction, and takes about 5 minutes. Dubbed the “breast pap test,” its purpose is to identify any abnormalities early, just as a regular pap test identifies problems that may develop into cervical cancer.
It’s long been known that nipple fluid can be used to assess increased breast cancer risk. A precursor to cancer is often atypical hyperplasia, an abnormal overgrowth of cells in the milk ducts, cells that may or may not eventually become cancer. When fluid is withdrawn from the breast, some of the duct cells come with it, and a pathologist can examine the fluid and detect any abnormal cells it holds.
So will Halo become a regular part of our health-care routine, just as a pap test currently is?
Maybe. But right now, I believe there are still too many questions about Halo for any of us to ask for it at our annual physical.
In the single large study done, involving 500 women, only 190 were able to produce nipple fluid using Halo. Of those who did, the samples from 50% didn’t contain enough ductal cells to assess. Of the remainder, 5 showed cells with atypical hyperplasia, placing these women at a 4 to 5 times greater risk for breast cancer than the general population.
That translates to 1% of the study. Or, more simply, using Halo, about 1 of 100 women will learn she has atypical hyperplasia, and is at increased risk for breast cancer.
Halo isn’t a diagnostic tool, like a mammogram; it’s a risk assessment tool. Of the 500 women in the test, 62% never even got out of the starting blocks; Halo wasn’t able to withdraw any fluid from their nipples. And of the remainder, 97% tested normal; no increased risk.
The question is, just how far do we want to go to assess risk?
I believe Halo is part of a growing minefield of early-detection programs, such as the full-body scan designed to detect tumors in asymptomatic (healthy) people. Body scans cost between $600 and $3,000. Halo is relatively inexpensive, at $75-$100. Still, is this outlay of cash worth it? Yes, of course, if you’re one of the infinitesimal minority who benefits by the procedure.
But Halo doesn’t diagnose breast cancer. Of the women who eventually get breast cancer, Halo would have been no use at all to the 15% whose cancer is lobular, rather than ductal. A more sophisticated nipple fluid collection method, ductal lavage, is often recommended for women already determined to be at high risk, such as BRCA carriers. For these women, whose risk of breast cancer can be as great as 70%, keeping a very close eye on their breasts by every method possible is key. Perhaps, if Halo becomes as effective as ductal lavage at withdrawing nipple fluid, it may someday be a regular part of the health regimen for women already identified as high-risk.
But for the vast majority of us, women at no known risk? I think an annual mammogram, beginning at age 40, is still the way to go. Until Halo (or a similar method) becomes more effective, it shouldn’t be adopted as a standard of care. The price we’d all pay—in time and dollars both—simply doesn’t support the results.
Published On: March 22, 2009