Frequently Asked Questions
Why is breast cancer risk assessment so important?
Is HALO a diagnostic test?
Does HALO replace mammograms?
What about family history?
How does the HALO Breast Pap Test work?
Who should have HALO and how often?
Is the procedure painful?
How many women produce fluid?
What if I don’t produce fluid?
If I have atypia, does it mean I have breast cancer?
What do I do if I get an abnormal result?
How long does it take to get results?
Is HALO FDA approved?
Is HALO reimbursed by my insurance company?
Can I have a HALO if I have breast implants?
Can I have a HALO if I’ve had a breast reduction?
Can I have a HALO if I have a nipple ring?
Is color of Nipple Aspirate (NAF) important?
Can I have a HALO test if I am breast feeding?
[ click here to view FAQs in Spanish ]
- Why is breast cancer risk assessment so important?
1 in 8 women will develop breast cancer in their lifetime, but to date, it’s been very difficult to identify who is at risk. Women under the age of 40 are not usually getting regular mammograms. For women over 40, mammograms often do not detect abnormal changes until about 8 years after changes have begun to take place. Mammograms are also not as effective in women with dense breasts. HALO is risk assessment tool that can help identify women at greatest risk, years earlier, allowing for earlier intervention and increasing chances for survival.
- Is HALO a diagnostic test?
No, HALO is not a diagnostic test. A diagnostic test confirms whether or not symptomatic (with symptoms) patients actually have a disease. HALO is a risk assessment test meaning that it helps physicians stratify an asymptomatic woman’s risk of developing breast cancer in the future.
- Does HALO replace mammograms?
No, HALO is a complement to mammograms. Mammograms look for lesions (cancer) and are most effective as women age. HALO is looking for abnormal cells, years before they might turn into a lesion, and the test is effective in women as young as 25. If you already have a growth in your milk ducts when you first have a HALO test, it’s possible that the affected duct could be blocked so that HALO could not collect a fluid sample. This is why it’s important to continue with routine mammograms and breast exams.
- What about family history?
Those who have a mother, sister or daughter with breast cancer are 2 to 3 times more likely to develop the disease. Those who have atypia are 4 to 5 times more likely to develop breast cancer. HALO will help you and your doctor identify cellular changes, closely monitor them and develop an optimal care path.
- How does the HALO Breast Pap Test work?
HALO combines warmth, massage and suction to bring nipple aspirate fluid (NAF) to the surface. NAF is found in the milk ducts where 95% of all breast cancers originate. The entire cycle is five minutes and is easily incorporated into your well-woman visit. If you produce fluid, the sample is then sent to the lab and analyzed for cellular changes.
- Who should have HALO and how often?
This is an annual test for all non-lactating women 25 and over. Women over 55 tend to decrease their production of NAF and mammograms become more effective at this stage. Women over 55 who produce NAF should continue to have annual HALO tests.
- Is the procedure painful?
Most women find the test easy to tolerate. In a clinical study with 500 women, 88% said they would recommend it to their friends. On a 1 – 10 scale, the average discomfort rating for the HALO was about a 4 while those same women rated their mammogram an 8.
- How many women produce fluid?
About half of all women will produce fluid. Not producing fluid with the HALO test is considered a normal result, meaning you are at normal risk, not elevated risk for developing breast cancer.
- What if I don’t produce fluid?
If you don’t produce fluid, this is considered a normal result. You are at normal risk, not elevated risk for developing breast cancer. Women who do not produce NAF one year may produce NAF the next year therefore, the HALO Breast Pap Test should be conducted annually.
- If I have atypia, does it mean I have breast cancer?
No. It simply means you are at a higher risk that someone without atypia. In fact, only about 1% to 2% of women screened have atypia and often atypia corrects itself, especially if lifestyle changes are made such as diet, exercise and reducing alcohol intake.
- What do I do if I get an abnormal result?
There are specific carepaths for your consideration. In general, if you have an abnormal result you will likely be referred to a breast center. The breast specialist has several options in 3 broad categories:
- Full risk assessment questionnaire and counseling about preventive measures
- Diagnostic mammogram, Ultrasound, or MRI
- More aggressive options to include medication such as tamoxifen; procedures like ductal lavage, ductoscopy, or ductal incisions, etc.
- How long does it take to get results?
Typically it takes three to five days. Your doctor’s office will notify you of the results.
- Is HALO FDA approved?
Yes, HALO is FDA approved.
- Is HALO reimbursed by my insurance company?
The collection of NAF with the HALO system is not yet reimbursed by insurance companies. Contact your doctor about your cost for the HALO test. If you produce fluid during the HALO test, your doctor’s office will send the sample to the lab to be evaluated. The charges associated with the lab are covered by most insurance companies.
- Can I have a HALO if I have breast implants?
It depends on the type of implant. If your incision is not around the entire nipple, you may have the HALO.
- Can I have a HALO if I’ve had a breast reduction?
It is best to discuss this with your doctor. You may be a candidate for HALO if your entire nipple was not removed.
- Can I have a HALO if I have a nipple ring?
Yes, however you must remove the ring(s).
- Is color of Nipple Aspirate (NAF) important?
No. NAF can be any color.
- Can I have a HALO test if I am breast feeding?
No. You must wait at least 6 months after your last breast feeding to have a HALO test.
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