TRINITY — Gynecologist Wanda Torres is always on the lookout for signs of cancer: a lump in a woman's breast, a lesion on her mammogram results.
But what if Torres could look for breast cancer before it develops?
That's what she hopes to do with a new screening device called the Halo Pap Test for the Breast. The test aims to detect precancerous cells in breast fluid up to eight years before anything would show up on a mammogram.
Torres is recommending it as an annual test for all her patients ages 25 to 55, even those with no known risk factors, such as a family history of the disease. For women ages 40 and older, the test would complement — not replace — regular mammograms.
"We're trying to detect cancer much earlier," said Torres, whose Suncoast Women's Care in Trinity is the first Tampa Bay area office with the device. "You wish you could detect it earlier than in a mammogram."
Numerous studies have shown that finding abnormal cells in breast fluid can be a good predictor of future breast cancer development. Most breast cancers originate in the ductal systems and progress from "precancerous cells," which have minute changes that can be see under a microscope.
A woman who has such atypical cells has a four to five times greater risk of developing breast cancer than women who do not, Torres said.
But the methods for collecting this fluid — including fine needle aspiration — can be time-consuming and expensive and are geared toward women who already know they may be at high risk for breast cancer because of other factors.
Enter the Halo system, billed as the first quick and noninvasive way to collect the fluid from a wider variety of women. The device uses adjustable breast cups to collect the fluid through a five-minute cycle of compression, heat and gentle suction.
Many women do not produce the fluid to test. As part of the only clinical trial to test the Halo device, researchers found less than 40 percent of the 500 participants produced fluid.
Of those who did, about 10 percent had samples that showed some benign, minimal changes at the cellular level; 3 percent showed moderate to severe abnormalities. None of the 500 women had any symptoms or history of breast cancer.
So what does a woman do with that kind of information? Torres said women whose samples show abnormalities might get a follow-up mammogram or ultrasound to see if anything has developed. She might decide to see those women again in six months rather than a year.
In short, the surveillance light goes on.
Insurance does not yet cover the Halo test, which received federal approval in late 2005. A policy bulletin issued by Aetna, for instance, says it needs to see more studies to establish the device's clinical value.
Torres is charging her patients about $125 for the test.
About 130 doctors offices nationwide are using the Halo, said Bob Jeney, a regional sales representative for the California-based manufacturer, Neomatrix.
Jeney said the Halo represents a "shift in the paradigm" for doctors, which is why it is slow to catch on.
"We treat breast cancer today like the way we used to treat heart disease," he said. "We wait until they have symptoms."
Halo's makers say the device has the potential to become the lifesaver that the cervical Pap test has been. Since the cervical Pap smear was introduced in the 1950s, the death rate from cervical cancer has declined more than 70 percent.
That claim is premature for Halo, but the device does have a lot of potential, said Dr. Deanna Attai, a California-based member of the American Society of Breast Surgeons.
Women under age 40 especially can benefit because they're not getting regular mammograms, she said. The women who probably would not benefit: older women with a history of breast cancer, because they should be getting increased monitoring, anyway.
"It's another piece of the early detection puzzle," she said. "What I think it can do is help us better identify the woman who truly is at high risk and better counsel her about what her options are."
Jodie Tillman can be reached
at [email protected]
or (727) 869-6247.