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HALO® Breast Pap Test. HALO® Breast Pap Test.   Find asymptomatic woman and perform a risk stratification method via the HALO® Breast Pap Test.  

HALO is the only fully automated, noninvasive system used to assess a woman’s individual risk for developing breast cancer.  HALO is FDA-cleared for the collection of nipple aspirate fluid (NAF) for cytological evaluation. Designed for women 25 and older, the simple, 5-minute test is well tolerated and is included as part of the annual well-woman visit in a physician’s office. HALO uses a combination of warmth, massage and suction to elicit nipple aspirate fluid NAF from the milk ducts where almost all breast cancers originate. The fluid is then sent to your lab for cytologic evaluation to determine if the patient is at high risk for developing breast cancer. If your patient produces fluid with atypia or abnormal cells, she is 4 to 5 times more likely to develop breast cancer compared to someone who does not produce fluid. If your patient has atypia, this doesn’t mean that breast cancer is inevitable, but it does mean that her breast health must be monitored more closely. Most likely she’ll be referred to a breast specialist for a complete risk assessment and possibly further imaging studies. HALO identifies women who are at highest risk for developing breast cancer allowing for risk reduction, strategies, and closer breast health surveillance. If breast cancer develops, it is more likely to be identified in the earliest, most treatable stages where outcomes are considerably better. It is important to remember that the HALO Breast Pap Test is not a diagnostic for breast cancer and it does not replace routine mammograms or breast exams.

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HistoryHistory

The science behind HALO is not new. Fifty years of research have confirmed the ability to detect early cellular changes through the analysis of NAF and to use NAF to identify high-risk women, but until now, there has been no practical way to collect NAF. HALO provides the opportunity for women and their doctors to at last take advantage of this science in an easy, proven process that provides personalized risk assessment. It enables women to be proactive about their breast health and opens the possibility of preventing breast cancer.Multiple studies involving over 20,000 women followed for up to 25 years produced consistent results. Dr. Papanicolaou first discovered the utility of NAF in the 1950s, but, until now, lack of a practical method of collecting the fluid has limited its use primarily to the research setting.

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ScienceScience

HALO should not be confused with ductal lavage. Ductal lavage is invasive and time-consuming so its use was limited (by FDA and by practicality) to women already identified as high risk. Therefore it didn’t add much as a risk assessment tool. Instead it was used as a semi-diagnostic. While NAF is a proven predictor of breast cancer risk, it is a poor diagnostic for cancer. Risk assessment using NAF cytology follows a similar model to the cervical Pap, but there are some key differences. In both cases, epithelial cells follow a similar progression from normal to abnormal to malignant cells, though abnormalities often self correct. With the cervical Pap, cells are scraped directly from the cervix, whereas NAF cytology is dependent on cells exfoliating into the breast fluid and subsequent collection of that fluid. While studies show that women who don’t produce fluid or produce acellular fluid are statistically at lower risk, we can never be certain that an individual woman’s lack of fluid or cells is due to healthy breasts rather than our inability to collect fluid from the entire ductal system. For this reason we act on the “positives” and draw limited conclusions (i.e., “normal risk”) from the negatives. Like most screening tests, NAF cytology cannot be used to rule out the possibility of cancer. HALO is not a replacement for mammograms or breast exams; it is an adjunct to current breast screening routines. Care Path for Women with Abnormal Results

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Science Science Cont.Cont.

Atypia alone cannot determine appropriate follow up care; these women need a complete risk assessment, usually by a breast specialist. If a woman has atypia but no other significant risk factors, she might be upgraded to a diagnostic mammogram or ultrasound, and simply be monitored more frequently. However, atypia along with another significant risk factor quite often elevates risk above the 20 to 25% level where the American CancerSociety suggests MRI. Women at very high risk are typically referred for enhanced imaging, and will be counseled on risk reduction options including lifestyle changes and chemoprevention. Biopsies or surgical options should not be pursued unless follow up diagnostics reveal suspicious findings.Some Radiologists feel pressured to find abnormalities with imaging if the patient has atypia. But it’s important to remember that NAF abnormalities are at the cellular level; suspicious findings on follow up imaging are a possibility but should not be expected.

 

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Links to VideosLinks to Videos

You can access additional information concerning HALO at our website: www.neomatrix.com or at http://www.neomatrix.com/resources/Breast-Health-Literature.aspx I would also like to recommend viewing our five minute patient video which is available on our site that will provide a quick overview on HALO. Here is the direct link for the video:  http://www.neomatrix.com/halonaf/NeoMatrix-Patient-Video.aspx

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TakeawayTakeaway

The key takeaway is that NAF cytology gives us an objective measure of an individual woman’s risk, helping us to triage patients and allocate our resources more effectively; I think in the long run, this will help us prevent some cancers and find others at an earlier stage than we might have otherwise.