The HALO Breast Test

The HALO Breast Test

What is the HALO Breast Test and why is it recommended?
More than 200,000 are diagnosed annually with breast cancer and nearly 40,000 die. While most attention has been focused on the incidence of breast cancer in post-menopausal women, statistically, 23 percent of all breast cancers occur in women under 49 years of age. In fact, one in every 229 women between the ages of 30 and 39 will be diagnosed with breast cancer within the next 10 years.

The HALO Test is a simple, 5-minute, non-invasive breast screening and risk assessment exam recommended for women 25 years of age and older. The test can detect early cellular changes within the breast ducts, the area where more than 90% of breast cancer begins.

What is the difference between a “screening test” and a “diagnostic test”?
A screening test is used to assess asymptomatic patients. A screening test is designed to identify individuals who might be at risk of having or developing a disease. A screening test is designed to be sensitive (i.e. to detect as many at risk as possible) but not to be specific (i.e. it does not diagnose a disease). The purpose of screening is to test as many persons as possible. For patients who have a positive HALO screening, additional tests will be recommended. Tests that are more specific are called diagnostic tests. They are done to look more closely for possible disease.

The HALO screening is similar to cholesterol screening used to assess the risk of cardiovascular disease. An elevated cholesterol level does not indicate heart disease; it indicates an increased risk of heart disease. Another example is mammogram screenings. This test is looking for the presence of an existing breast lesion; additional diagnostic tests are recommended if something is identified.

How is the HALO test done? Is it painful?
The HALO uses a collection device that applies a combination of warm water massage and gentle suction to elicit Nipple Aspirate Fluid (NAF) from the breast. If NAF is expressed, the sample is sent to the laboratory for analysis by a trained pathologist, a process similar to sending fluid after a cervical pap test. The majority of women rate the exam as mildly uncomfortable, a 2-3 on a scale of 10.


Do all women produce fluid?
Approximately 50% of women will express fluid. If no fluid is returned, the assessment is considered to be “negative” and places you in a low risk category for developing breast cancer. However, like a negative mammogram or negative cervical pap exam, a low risk HALO exam does not guarantee you will always be cancer free. The test should be repeated annually, along with a clinical breast exam and an infrared scan.



What percentage of women tested have atypical cells in the fluid sample?
Approximately 1% of NAF expressed from asymptomatic women contains atypical cells. This represents a 4-5 time relative increased risk of developing breast cancer at some point in time. The NAF can be reported as follow:

Risk Level 1 – fluid only;
Risk Level 2 – fluid and normal cells;
Risk Level 3 – fluid and atypical cells;
Risk Level 4 – fluid and dysplastic cells; suspicious for malignancy

The presence of cells dictates the next steps. Normal cells and atypical cells are benign, but indicate a slightly increased risk. If you are identified as Risk Level 3 or 4, more specific assessments will be suggested, which could include infrared imaging, diagnostic mammography, ultrasound or MRI. The Tenpenny Breast HEALTH Center at OsteoMed II has developed proprietary assessment and intervention protocols for each risk level.



Does the presence of atypical cells mean that I have cancer or that I will get cancer in the future?
No. The presence of atypical cells means you may have an increased risk of breast cancer. For example, an elevated cholesterol level represents an increased risk of heart disease, but does not mean you have heart disease or even that heart disease will develop.





The HALO helps to identify women who are at increased risk, allowing for early interventions such as lifestyle changes, weight loss, smoking cessation and breast-smart supplements. An abnormal HALO also identifies asymptomatic women who need additional testing and closer surveillance.


What is the difference between the HALO assessment and Ductal Lavage?
Ductal lavage is an uncomfortable, invasive procedure indicated for women who have been identified as high risk. Ductal levage is used to confirm the presence of atypical cells coinciding with the abnormal mammogram findings. By contrast, the HALO exam is a non-invasive assessment of asymptomatic patients. The test is for identifying risk; it does not diagnose disease. Finding atypical cells with the HALO will necessitate additional tests and closer surveillance.





Who is the HALO test recommended for? How often should the test be done?

Approximately 1 in 2500 women will develop breast cancer by age 30; that relative risk increases to 1 in 200 by age 40. Routine mammograms are not recommended for women in their 20s and 30s because:
1) radiation exposure, accumulated over additional years, may promote breast cancer;
2) physical pain from the breast compression during mammography is increased;
3) there is often increased anxiety and unnecessary testing due to many false positives;
4) potential for over treatment of areas that are not life threatening;
5) false reassurance from negative studies that miss cancer because the area is too small or because breasts were too dense; and
6) the increased emotional anxiety that also impacts breast health.

HALO is recommended for all women 25 years and older. Combining HALO with a non-invasive, radiation-free infrared scanning is the best possible health screen and risk assessment for your breasts.

Is the HALO assessment covered by my insurance?
We have made the HALO exam very affordable because it is not currently covered by conventional insurance. However, if NAF is expressed, the laboratory costs will be covered by your insurance.

Why is the HALO test called a “breast pap test”?
Dr. George Papanicolaou, the inventor of the cervical pap test, published a paper in 1958 outlining what should be done with NAF. Hence, he has been acknowledged by calling the HALO exam the “pap test” for the breast. A good time to get an annual HALO test done is when you have your annual cervical pap exam completed.