Pipeline

MenaCalcâ„¢ Platform

The MenaCalc™ test is a next generation driver-based assay that measures the aggressiveness of a patient’s tumor and predicts the likelihood the cancer will spread. Information provided by the MenaCalc™ test allows oncologists to personalize treatment strategies and improve outcomes based on the patient’s individual tumor biology. The MenaCalc™ test is intended for use in patients with all molecular subtypes of early stage (stage 1-3) invasive breast cancer including triple negative (TNC) and Her2-positive (HER2+) breast cancer as well as squamous cell carcinoma of the lung, and a number of other epithelial-based tumors.

The MenaCalc™ test  is a fully automated quantitative immunofluorescence assay performed on formalin-fixed paraffin-embedded (FFPE) tissue from a biopsy. Using proprietary digital pathology and image analysis methods, the assay quantifies expression levels of the Mena protein and the Mena11a isoform. The Mena protein and its isoforms are key potentiators and modulators of cellular phenotype, migration, invasion, and metastasis. Overexpression of MenaINV and downregulation of Mena11a in tumor cells correlate with metastatic potential. Clinical studies have demonstrated the MenaCalc™ score is associated with increased risk of systemic metastasis and decreased overall survival.

In January 2016, the MenaCalc™ assay was 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 MenaCalc™ Breast assay as shown in Figure 1 is representative of a high MenaCalc™ score, which is associated with higher risk for the development of metastasis.


Figure 1: Overexpression of Pan Mena (yellow) is shown
  in this tumor 
section from a patient with early stage 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 MenaCalc™ Breast assay as shown in Figure 2 is representative of a low MenaCalc™ score, which is associated with lower risk for the development of metastasis.

Figure 2: Overexpression of the Mena11a isoform (red) is shown
in this tumor 
section from a patient with early stage invasive breast cancer.

Clinical Summary

Results from a study of 403 patients with axilliary node-negative invasive breast cancer confirming earlier results that MenaCalc™ Breast was a strong predictor of disease-specific survival. Patients who had high MenaCalc™ scores had a 2.2-fold greater risk of death compared to patients with low MenaCalc™ scores when controlled for other traditional clinical factors. Results from this study was published in BMC Cancer by Forse et al. in June 2015.

In April 2015, positive results were presented from a clinical study of 201 patients demonstrating MenaCalc™ Lung as an independent prognostic factor and predictor of metastasis in patients with early stage NSCLC at the American Association for Cancer Research (AACR) Annual Meeting. Results from this study demonstrated that MenaCalc™ Lung scores were significantly higher in patients with Squamous Cell Carcinoma as compared to other subtypes. High MenaCalc™ Lung scores were associated with decrease 5-year disease specific survival in all patients, and were significantly associated with survival in the squamous-only population.

Key Advantages

  • Next generation diagnostic based on the biological mechanisms that drive metastasis;
  • High analytical accuracy, reproducibility and precision;
  • For use in patients with all subtypes of early stage (stage 1-3), invasive breast cancer including estrogen receptor-positive (ER+)/HER-negative disease, triple negative and HER2+ disease;
  • Mena expression is linked to several cancers including prostate, squamous cell carcinoma of the lung and colorectal cancer;
  • 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.