MetaStat, Inc. announced the completion of an analytical validation study of its MenaCalc clinical test, which demonstrated strong overall assay performance and precision with mean coefficient of variation (%CV) of only 2.3% (Range 0.07-6.95). MenaCalc™ is a next generation driver-based prognostic test to predict the risk of developing cancer metastasis in patients with invasive breast cancer, squamous cell carcinoma of the lung and a number of additional epithelial-based cancer tumors. The MenaCalc™ results, reported as a MenaCalc™ Score, better inform physicians in making treatment decisions to enhance outcomes.

In this study, MetaStat assessed the overall assay performance, imaging, and scoring performance of the fully-automated quantitative immunofluorescence clinical MenaCalc™ test using FFPE tissue samples (n=28) from patients with invasive breast cancer. MenaCalc™ was shown to have strong assay performance (day-to-day reproducibility) as measured by linear regression analysis showing Pearson's R greater than 0.85 and linear slopes greater than 0.98 with a mean %CV of 2.3% (Range 0.07-6.95). Further, imaging and scoring performance (run-to-run precision) was also highly precise with Pearson's R and linear slopes greater than 0.99 as well as %CV of 0.45% (Range 0.02-2.32).