Pipeline

MetaSite Breastâ„¢

The MetaSite Breast™ test is a next generation diagnostic assay that measures the aggressiveness of a patient’s tumor and predicts the likelihood the cancer will spread. Information provided by the MetaSite Breast™ test allows oncologists to personalize treatment strategies and improve outcomes based on the patient’s individual tumor biology.  The MetaSite Breast™ test is intended for use in patients with early stage (stage 1-3), invasive breast cancer who have node-negative or node positive (1-3), estrogen receptor-positive (ER+), HER2-negative (HER2-) disease.

The MetaSite Breast™ test is a fully automated immunohistochemistry-based assay performed on formalin-fixed paraffin-embedded (FFPE) tissue from a biopsy. Using proprietary digital pathology and image analysis methods, the assay identifies and quantifies the number of micro-anatomical structures called MetaSites™, consisting of a Mena expressing cancer cell, an endothelial cell and a perivascular macrophage. MetaSites™ have been shown to be the portal of entry for cancer cells into the blood stream contributing to the development of cancer metastasis. Clinical studies have demonstrated that the number of MetaSites™ are significantly and directly associated with increased risk of metastasis.

The MetaSite Breast™ assay is analytically validated under CLIA in our state-of-the-art CLIA-certified commercial laboratory located in Boston, MA.

High-Risk Patients

Patients with aggressive tumors that are more likely to spread are stratified as high-risk.  High-risk patients are often treated with adjuvant chemotherapy to prevent disease recurrence and the development of systemic metastasis.

Data from the MetaSite Breast™ assay as shown in figure 1 is representative of a high MetaSite™ score, which is associated with higher risk for the development of metastasis.


Figure 1: Multiple MetaSites™ are visible and circled in this tumor
section from a patient with ER+ invasive breast cancer.

Low-Risk Patients

Patients with less aggressive, indolent tumors that are less likely to spread are stratified as low-risk. Low-risk patients can be spared from the harmful side effects and expense of chemotherapy as the risks of adverse events and the development of future malignancies associated with adjuvant chemotherapy outweigh any marginal benefits.

Data from the MetaSite Breast™ assay as shown in figure 2 is representative of a low MetaSite™ score, which is associated with lower risk for the development of metastasis.


Figure 2: One MetaSite™ is visible and identified in this tumor
section from a patient with ER+ invasive breast cancer.

Clinical Summary

Data from a 481 patient correlative clinical study was completed which demonstrated a positive association between MetaSite™ score and risk of distant metastasis in women with ER-positive/HER2-negative breast cancer. In this subgroup, the MetaSite™ score outperformed the validated IHC4 score, used as a surrogate for the prognostic information provided by the Oncotype DX score. Results from this study were published in the Journal of the National Cancer Institute by Rohan et al. in August 2014.

Results from a case-controlled 295 patient prospectively defined prognostic study using the fully automated of MetaSite Breast™ assay independently verified results from the Rohan et al. study. The MetaSite™ score was significantly and directly associated with risk of distant cancer metastasis for both the intermediate and high risk groups.

Key Advantages

  • Next generation diagnostic test based on the biological mechanisms that drive metastasis;
  • High analytical accuracy, reproducibility and precision;
  • Clinically actionable results for the majority of early stage breast cancer patients;
  • Utilizes FFPE tissue samples and readily fits into the current diagnostic paradigm;
  • Rapid analysis and reporting, turnaround within 14 business days;
  • Consistent reproducibly, results generated from our state-of-the-art CLIA-certified laboratory; 
  • Billable to the well-established reimbursement code 88361, no undefined or stacked code