A new test may be able to identify women at risk for breast cancer long before a lump appears on a mammogram, according to the makers of the new test, called Halo? Breast Pap Test System.
Drawing on the record of one of the oldest and most successful models of health screening, the Cervical Pap Test, NeoMatrix is showcasing the first automatic, noninvasive test of its kind, at this week’s 55th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG).
Designed to detect abnormal cells in the breast years earlier than a lesion might be found on a mammogram or a clinical breast exam, the HALO System can identify benign breast disease, which has been linked to breast cancer and is considered a risk factor, as well as abnormal ductal cells that can be precursors of cancer.
Breast cancer, which virtually always originates in the ductal system, develops in a similar manner to cervical cancer and progresses through identifiable cell development stages that can be detected in Nipple Aspirate Fluid. The developer of the Cervical Pap Test, Dr. George Papanicolaou, was also first to demonstrate that abnormal cells could be identified from NAF samples.
The FDA-approved Halo Breast Pap Test System combines a device for collecting Nipple Aspirate Fluid (NAF) along with a laboratory analysis of ductal cells contained in the fluid. Because 95% of breast cancer originates in the breast ductal system, the presence of abnormal precursor cells in NAF may allow identification of breast cancer risk up to eight years prior to the appearance of a lesion on mammogram or self-examination.
The Halo system uses breast cups similar to a breast pump, that generate mild compression on both breasts while applying heat over a five-minute cycle. Toward the end of the cycle, gentle suction is initiated to retrieve ductal fluid.
According to a company news release, the noninvasive five minute procedure is the first designed for screening in the Ob-Gyn office, or other primary care setting. Unlike current methods of breast cancer screening, which are capable of detecting tumors that have already developed, the HALO Breast Pap Test is designed to identify patients at risk before a lesion is detectable. This may be particularly useful in younger women who are not yet getting mammograms or are at an age when mammograms are not as sensitive.
Dr. Steve Drosman, a San Diego Ob-Gyn who has pioneered the new office-based screening method, says the current screening technologies are geared toward finding a lump as soon as possible, whether it be through a physical exam or with mammography.
“The HALO is the first device to allow the Ob-Gyn to implement a screen in their office to identify who is at risk,” Drosman said in a press release. “The HALO system provides a simple, noninvasive tool to collect ductal fluid in minutes and can easily be incorporated into a well-woman visit.”
A number of research studies have demonstrated that ductal fluid excreted from the nipple can be used to identify a woman’s specific risk of breast cancer. A woman with abnormal cells in the fluid has a four to five times greater risk of developing breast cancer than women who do not produce fluid.
“Since implementing this test, we have identified several women at risk who would otherwise remain undetected — none of whom had other risk factors,” said Drosman. “By identifying these patients, we can send them to a surgeon or breast center where they can be managed as a high-risk patient, something breast specialists do routinely.”
In the National Cancer Institute’s report, “The Nation’s Investment in Cancer Research 2006: Cancer Prevention, Early Detection and Prediction,” the NCI calls for more accurate methods of predicting who is at high risk for developing cancer.
The introduction of the HALO Breast Pap Test has been compared to the introduction of the Cervical Pap Test in the 1950s, which is widely credited with reducing cervical cancer death rates by more than 70 percent through the identification of abnormal cells in the cervix. Whether the same can be said for the breast pap test remains to be seen, but it is likely that the screen will be adopted by more OB-GYNs as oncologists push for even earlier identification of cancer.