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Overview
 There
are several methods physicians can utilize to assess a woman's
risk for breast cancer, including personal and family history,
statistical models, pedigree construction, and genetic mutation
analysis. Although these risk assessment tools can provide
physicians with important information, they have limitations
that can lead to over-prediction or under-prediction of risk
in certain populations.
For example, the Gail Risk Model is a widely used risk assessment
tool that calculates risk for populations of women. It is
based on historical factors such as family history, age,
etc. However, it underestimates risk in many individuals.
The information from the FirstCyte® Breast Test complements the existing tools for evaluating breast health by providing real time, cell-based information that is unique to each individual. In this way, the FirstCyte Breast Test helps refine risk assessment from a broad population to more specific individuals.
Researchers have found that women who get breast cancer often have certain risk factors in common. These risk factors include:
- Have had breast cancer in the past
- Have close relatives who have had breast cancer
- Have a 5-year Gail Risk Model of 1.7% or greater
- Have a BRCA1 or BRCA2 gene mutation
Combining a patient's history with atypical cytologic findings allows you to know more now about your patient's individual breast cancer risk.
Risk Stratification:
An Important Approach in Managing the High-Risk Patient
Risk stratification can be defined as identifying individuals at particularly high risk for an outcome. There is ample precedent for risk stratification in other areas of medicine:
- Cholesterol levels and blood pressure define individuals at high-risk for cardiovascular disease.
- Low bone density defines those at high-risk for bone fracture.
The ability to evaluate cells in the breast provides physicians with a way
of refining current risk assessment by sub-stratifying patients who are at
highest risk for breast cancer. The presence of abnormal cells provides a cellular
indicator of further elevated risk for an individual patient. Combining cellular
indicators of risk (i.e., the presence of cellular atypia) with historical
risk factors such as family history or Gail Risk Model score can refine or
individualize a patient's risk assessment, enabling further risk stratification.
The FirstCyte Breast Test can collect atypical cells
The FirstCyte Breast Test is a minimally invasive method of collecting cells
from a woman's breast. The sample is then sent to a lab for analysis to determine
whether the cells are normal or atypical. In
a
multicenter clinical trial1 of ductal lavage with more than 500 high-risk women
who had nonsuspicious
mammograms and physical exams within the last 12 months:
- Atypical cells were found in 24% of subjects who underwent lavage.1
- Ductal lavage was 3.2 times more likely than nipple aspiration
in detecting the presence of cellular atypia (p=0.001).
1
Findings of a MultiCenter Clinical Trial 1
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Nipple Aspiration |
Ductal Lavage |
| Median epithelial cell yield |
120 per breast |
13,500 per duct |
| Benign |
17% |
54% |
| Mild atypia |
6% |
17% |
| Marked atypia |
3% |
6% |
| Malignant |
<1% |
<1% |
Inadequate cellular material
for diagnosis (ICMD) |
73% |
22% |
Cytological Analysis of Breast Ductal Epithelial Cells
The cytological analysis of breast ductal epithelial cells is an accepted clinical procedure. Over the years, several techniques have been used to collect ductal epithelial cells for cytological analysis2. These techniques have included:
- Collection of spontaneous nipple discharge;
- Collection of nipple discharge elicited through aspiration;
- Collection of cells by random fine needle aspiration.
Limitations of Breast Ductal Cell Collection Techniques
Many of the current cell collection techniques used in the past have clinical shortcomings.
Nipple aspiration
- Collects few ductal epithelial cells making cytology interpretation difficult
- Ability to collect cells from the terminal ductal lobular unit is questionable
- Pooled sample prevents tracing cells to a specific ductal system
Random Fine Needle Aspiration
- Can be invasive and painful
- Cells cannot be traced to a specific ductal system
FirstCyte Breast Test –
An Alternative Breast Ductal Cell Collection Technique
The FirstCyte Breast Test - an efficient, minimally invasive ductal cell collection method.
- The FirstCyte Breast Test directly accesses individual breast ductal systems and produces higher cell yields than nipple aspiration.
- The FirstCyte Breast Test can be repeated so that the cellular status of a specific duct can be tracked over time.
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