HALO Breast Pap Test Information Site

Everything you need to know about the HALO Breast Pap Test

The HALO Effect

Breast cancer is a leading health concern among women in the U.S. Over 200,000 new cases are identified every year, resulting in over 40,000 deaths annually. In spite of the fact that more than $3 billion is spent annually in the U.S for breast cancer screening, only modest progress in reducing the death rate has been achieved.

 

 

The Pap test is arguably the most successful cancer screening technology in history. The effectiveness of the Pap test in reducing the death rate of cervical cancer is directly related to the ability to determine precancerous conditions in the cervix before a cancer forms. Combined repeated testing, i.e. annual well-woman visits, the Pap test's simplicity and low cost led to widespread adoption. The annual death rate from cervical cancer has decreased over 70% since its introduction.

 

A noninvasive "Pap Test for the Breast" designed for the primary care setting may yield similar results, if simplicity and low cost lead to widespread adoption of Nipple Aspirate Fluid (NAF) cytological screening for benign breast disease. Most all breast cancers begin in the milk ducts; breast ductal epithelium undergoes pre-neoplastic changes that are recognized histologically and cytologically. This progression of disease is quite similar to that of cervical cancer. Just as an abnormal Pap test is an important tool in identifying cellular changes in a woman's cervix, the same applies to cellular changes within her breast ducts. There is a strong correlation between benign breast disease and the risk of developing breast cancer.

 

The gynecologist is on the front line of breast health in the U.S. According to the most recent American College of Obstetrics and Gynecology Guidelines for Women's Health Care, Breast Disorders, ACOG Recommendations- "The American College of Obstetricians and Gynecologists recognizes the obstetrician-gynecologist's role in diagnosing and treating breast disease. The College has adopted the goals of assisting and educating obstetrician-gynecologists in the diagnosis and treatment of benign beast disease and in the reduction of mortality from breast cancer." In regular practice, if a woman finds a suspicious lump in her breast, her first call is almost always to her gynecologist, who is then responsible for managing the case.

 

Every woman is at risk for developing breast cancer. Identified risk factors for breast cancer include several that cannot be changed: gender, age, family history, genetic changes, abnormal breast biopsy, early menarche, late menopause, as well as factors that can be changed including: parity, lactation, alcohol consumption, diet and exercise.

 

Breast cancer screening continues to generate some of the most intense debates in medicine. Screening recommendations are not standardized, the guidelines are not fully consistent for when to start screening, which tests to use, and how frequently a patient should be screened. To date, breast cancer screening guidelines include the utilization of a combination of three tests: clinical breast exam, breast self-examination and mammography. Clinical breast examination and the breast selfexamination have been long standing fundamentals in breast cancer screening and are recommended by most professional medical organizations, including the American College of Obstetrics and Gynecology as well as the American Cancer Society. The effectiveness of breast self-examination, however, has recently been challenged.

 

The American Cancer Society states: "Women at increased risk should talk with their doctors about the benefits and limitations of starting mammograms when they are younger, having additional tests (such as breast ultrasound or MRI), or having more frequent exams." The National Cancer Institute specifically states "Women who are at higher than average risk of breast cancer should seek expert medical advice about whether they should begin screening before age 40 and the frequency of screening."

 

It is clear that the establishment of an individual's risk for breast cancer is important in order for her physician and the patient herself to make informed choices regarding the appropriate approach to screening.

 

To appreciate the concept of screening for benign breast disease, and the analogy to the Pap test, it is important to understand the disease and it's course of development. Virtually all breast cancer originates in the epithelial cells that line the interior of the milk ducts in the breasts. Like cervical cancer, breast cancer progresses through identifiable stages of development.

 

Screening for benign breast disease is not a diagnostic test for breast cancer. Similar to screening for cervical cancer with the Pap test, NAF screening provides a sampling of the epithelial cells that line the interior of the duct. Like the Pap test, its greatest potential will occur with repeat annual testing and widespread adoption.

 

 

Nipple aspiration to collect breast fluid is a simple, acceptable, noninvasive technique that can provide information on the character of the breast epithelium in a significant proportion of women in whom breast biopsy is not clinically or ethically warranted.

 

This test lends itself to widespread adoption in the primary care setting, since women are used to visiting their gynecologist on a regular basis. The gynecologist is on the front line of breast health, and is the caretaker of the breast. The most recent American College of Obstetrics and Gynecology Guidelines for Women's Health Care, Breast Disorders, states that "Concerns regarding breast disorders are commonly raised at gynecologic or obstetrics visits. Ten percent of women younger than 21 years of age experience complaints related to fibrocystic conditions of the breasts. Such complaints are more common in the premenopausal period. With increasing frequency, women expect their obstetrician-gynecologists to assume responsibility for education, screening, counseling, and treatment concerning benign conditions of the breast." Further, the guidelines of the American College of Gynecology and Obstetrics include a clinical breast exam as part of the annual well-woman visit. If a woman finds a suspicious lump in her breast, she almost always visits her gynecologist prior to any other clinician.

 

As with the Pap test, the majority of tests will be normal. In the small percentage where atypia is found, risk management strategies are available to help reduce patient anxiety and mitigate the risk of developing breast cancer. An accurate assessment of breast cancer risk can guide clinical decisions about postmenopausal hormone therapy (HRT), when to start mammography and other screening tests, preventive tamoxifen therapy and prophylactic surgery.

 

Incorporating the HALO Breast Pap Test into routine practice will enable physicians and patients to monitor cellular changes within breast ducts earlier, before they develop into larger, potentially cancerous lesions that may much later be detected by conventional breast cancer screening modalities like mammography or manual breast examination.

 

The HALO Breast Pap Test is a simple, reliable method for NAF collection. NAF analysis is an objective assessment of a patient's breast health and can detect early warning signs of ductal cellular changes. Regular assessment and tracking of cellular changes in the milk ducts, where most breast cancer begins, enables clinicians and patients to take control of breast health.

 

The important point is, this new screening test could allow Gynecologists to identify high-risk patients that otherwise go undetected. It has particular value in identifying younger women. Many fortysomething women have breasts that are too dense to benefit from a standard mammogram, and women below 40 aren't routinely screened. The HALO test can be used on women as young as 25, providing a tool for those women who are harder to diagnose and are diagnosed with larger tumors. The most exciting aspect of this easy-to-use, cost-effective tool may be that it better enables Gynecologists to manage their breast imaging resource and apply the best diagnostic modalities to high-risk women, where they'll have the greatest impact on breast health care.

 

The HALO Breast Pap Test is the only fully automated, noninvasive NAF collection system specifically designed for use in a Gynecology setting.