HALO is the only fully automated, noninvasive system used to assess a woman’s individual risk for developing breast cancer. 

1. 1

2. 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.
2

3. History
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.
3

4. Science
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
4

5. Science 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 Cancer
Society 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.
5

6. Links to Videos
You can access additional information
concerning HALO at our website:
www.neomatrix.com or at
http://www.neomatrix.com/resources/Breast-Health-L
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
6

7. Takeaway
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.
7