Breast cancer is one of the most common types of cancer diagnosed in US women. In fact, it is one of the leading causes of cancer death in American women. To offer more effective and less toxic treatment, selecting therapies requires considering the patient and the clinical and molecular characteristics of the tumor.

Despite advances in early detection and understanding the molecular basis of breast cancer biology, many patients with early-stage breast cancer eventually suffer a recurrence. In most cases, the recurrences are distant metastases, suggesting that breast cancer is often a systemic disease from presentation.

The main prognostic factors associated with breast cancer are the number of lymph nodes involved, tumor size, histological grade, and hormone receptor status. However, some patients have a recurrence even though they have a tumor with good prognostic features. In this setting, breast cancer has multiple clinical presentations, and the therapy for it should be chosen according to the patient’s tumor characteristics, previous treatment, and performance status with the goal of improving survival without compromising their quality of life.

Our new prognostic test, Clarient Insight®Dx Breast Cancer Profile, has been clinically validated for women with early-stage, hormone-receptor-positive breast cancer. Unlike other assays used to determine the likelihood of recurrence, Clarient InsightDx uses a combination of pathology risk factors and molecular markers to categorize patients as either high or low risk.

• All patients receive local therapy and many receive adjuvant systemic therapy
   
• Although the underlying biology of a particular patient’s cancer can be characterized as high or low risk on the basis of several different models, most patients are cured by surgery  
    
  
   

• Estrogen binds to estrogen receptor and initiates the transcription of many genes, including PR, BCL-2, GATA3 and SCUBE2
   
• About 50% of these genes require FOXA1 to be present for optimum expression
   
• To be maximally effective, anti-hormonal therapy requires the presence of estrogen receptor on the tumor cell, the ability to transcribe key ER regulated genes, and the lack of significant oncogenic mutations
  
    
   

• A super-additive, non-linear mathematical algorithm incorporating clinical and key pathologic variables into a continuous risk score
   
• The Clarient InsightDx Breast Cancer Profile classifies patients at “Low Risk” or “High Risk” for recurrence.  Low risk patients have a risk score at or below 3.8. High risk patients have a risk score above 3.8. 
   
• Based on an independent study conducted at Clarient, patients in the low-risk group are expected to have a less than 5% rate of recurrence at 10 years, and patients in the high-risk group are expected to have at least a 10 times greater risk of recurrence than the low-risk group, on average.
   
• The test outperformed the commonly used and well-regarded Adjuvant! Online cancer treatment assessment tool, accurately identifying about 25 percent more low-risk patients.
   
• Enhances traditional pathology assessments with molecular markers (6 IHC, 1 FISH) and pathology staging risk factors (tumor size, tumor grade, and nodal status)
   
• Markers analyzed specifically in tumor cells, as opposed to homogenized tissue, which can include variable amounts of confounding cell types that compromise results
   
• Markers scored predominantly at the functional protein level, as opposed to intermediate levels, such as RNA transcripts, which cannot account for post-transcriptional processing