Diagnostics & Imaging Week

NeoMatrix (Irvine, California) has, in the FDA-cleared Halo Breast Pap Test System, what President and CEO Kevin Morton calls a "disruptive technology," but one that could have great benefits for women in knowing their risk for breast cancer.

The Halo Breast Pap Test System is based on the same technology as the Pap test for cervical cancer, only the breast system is a pump that collects nipple aspirate fluid (NAF). That's important because most breast cancers begin in the breast ducts, which secrete the NAF.

"[The product] changes the way that ob/gyns are doing business right now and mostly – historically – they've been focusing below the waist," Morton told Diagnostics & Imaging Week, referring to the "disruptive" nature of its product.

However, it's important because, he said, ob/gyns are "the caretaker of the breast."

The HALO Breast Pap Test, using gentle suction, uses adjustable breast cups to collect NAF. During the five-minute cycle, the HALO system generates mild compression on both breasts while simultaneously applying heat. Toward the end of the cycle, the HALO system initiates gentle suction to retrieve any fluid from the ducts.

The company said that virtually all, or 95%, of breast cancers originate in the ductal system of the breasts and progresses through identifiable stages of development. Acccording to a recent article in the New England Journal of Medicine, benign breast disease, which can present as abnormal cells, is an important risk factor for breast cancer.

That study, the company said, "joins a growing body of research" that suggests that the cytological assessment of breast duct fluid, or NAF, can identify a woman's specific risk for breast cancer.

The Halo Breast Pap Test System has been FDA-cleared for the collection of NAF for cytological evaluation for the determination and/or differentiation of normal vs. pre-malignant vs. malignant cells.

"We're not really finding breast cancer, we're screening for risk," Morton said. "So, what we do is we ID women who are high-risk just like the Pap [cervical cancer] test. The Pap test very seldom finds the cancer, but it finds abnormalities due to that cancer."

He said the goal is to determine the risk "before any cancer is there, which is obviously years before a mammogram picks it up."

The company said that since the introduction of the cervical Pap smear in the 1950s, the death rate from cervical cancer has declined more than 70%. However, the mortality rates for breast cancer have declined only modestly during the same period. Currently, about 3,700 women die of cervical cancer, while more than 40,000 die of breast cancer annually.

"For years, we have known that fluid from the breast ducts can be an excellent tool for evaluating the risk of breast disease in women of all ages," said Rosalyn Baxter-Jones, MD, ob/gyn and medical director of the Preventive Women's Health Care Medical Group (San Diego), in a company statement. "Until now, however, there were only invasive surgical or manual methods to collect samples, which impacted acceptance by both physicians and patients. The new HALO system provides a simple, noninvasive tool to collect ductal fluid in minutes and can easily be incorporated into a well woman visit."

Morton said the target patient for the device is a woman under the age of 50 who may have denser breasts and who, if they were to develop breast cancer, would likely have a more aggressive form of the disease.

Baxter-Jones, the first physician to use the system in clinical practice, recommends that all women between the ages of 25 and 55 have the test to evaluate their risk of breast disease.

Because the breast Pap test would be a new procedure for ob/gyns, Morton said the company has initially focused on education of physicians on the benefits of the device. For example, the company has had a booth for the past two annual meetings of the American College of Obstetricians & Gynecologists (ACOG; Washington).

The reception thus far from physicians has been "excellent," Morton told D&IW.

"So, this is something that they have to kind of change their behaviors," he said. "Yes, there's going to be a fair amount of education and that's exactly what our challenges are, [but the system] is very intuitive, it's very [comparable] to the Pap test," making education not that difficult.

He noted that the company's marketing approach, which will include regional roll-outs, also will focus on direct-to-consumer efforts.

"Really, we need a combination of a push-through [and] a pull-through," by educating physicians, including through a CME program, and then directing consumers to the physician.

Currently, the company is working on reimbursement issues with various payors. At the moment, the single-use device is self-pay, costing women from $50 to $55 out of pocket depending on the physician, Morton said.

Another company, Cytyc (Marlborough, Massachusetts), offers the FirstCyte Breast Test, which involves rinsing the inside of a patient's milk ducts to collect epithelial cells for cytological evaluation.

That test involves a three-step process of aspiration with the FirstCyte aspirator, insertion of a microcatheter about 1 cm in size into the nipple to withdraw the fluidm and preparing the sample for testing. A small amount of lidocaine is used in that procedure, the company said.