MetaStat, Inc. announced the successful completion of an analytical validation study of its MetaSite Breast™ clinical test, which demonstrated analytical precision greater than 97%. MetaSite Breast™ is a next generation driver-based prognostic test to predict the risk of developing metastatic disease in patients with ER+ invasive breast cancer. This information allows physicians to optimize treatment decisions and improve patient outcomes.

In this study, MetaStat assessed the analytical precision and accuracy of the fully-automated clinical MetaSite Breast™ test using FFPE tissue samples from patients with invasive breast cancer. The results were compared to the gold standard method originally developed at the Albert Einstein School of Medicine shown to predict metastatic disease in ER+ breast cancer patients (Rohan et al. JNCI 2014).

MetaSite Breast™ was shown to have analytical precision of greater than 97% with a mean percent coefficient of variation of 6.6% (n=35). Importantly, MetaSite Breast™ showed a high degree of accuracy with the reference standard by ROC analysis with AUCs (area-under-the-curve) of 0.84 and 0.90 for low and high risk cut-points, respectively.