Pipeline

MetaSite Breast™

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.

In December 2016, Dr. Joseph Sparano, principal investigator for MetaStat’s ECOG 2197 Cohort Study of the MetaSite Breast™ assay, presented study results at the 39th annual San Antonio Breast Cancer Symposium (SABCS). Importantly, MetaSite Breast™ was shown to provide useful prognostic information beyond the Genomic Health’s Oncotype DX Recurrence Score. Patients with high MetaSite Score (MS>17) and low Recurrence Score (RS<18) results had 9.7-fold greater risk (HR=9.7, 95%CI 1.8-54.1) of distant metastasis compared to patients with low MetaSite Score (MS<6) results. Patients with intermediate MetaSite Score (MS=6-17) and low Recurrence Score (RS<18) results had approximately 4.7-fold greater risk (HR=4.7, 95%CI=0.9-24.2) of distant metastasis compared to patients with low MetaSite Score (MS<6) results.

The MetaSite Breast™ test has been analytically validated under CLIA, tested in 6 clinical studies and over 1,700 patients and is available for clinical use in most states.

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.