MetaStat, a molecular diagnostic company, announced the successful 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.
"With successful analytical validation we are now advancing into our clinical validation studies with confidence," stated Mark Gustavson, PhD, Vice President Diagnostics of MetaStat. "Analytical precision is a prerequisite for clinical accuracy."
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).
"Findings published online, in BMC Cancer in June 2015, demonstrated the value of MenaCalc™ as a prognostic marker for survival in patients with node-negative invasive breast cancer," stated Douglas A. Hamilton, President and CEO of MetaStat.
"We are excited and look forward to providing physicians with commercial access to our MenaCalc™ test later this year, after we complete our clinical validation program. Data from the clinical program will support physicians’ decision to use the test and payors to reimburse for it."
MenaCalc is a quantitative immunofluorescent tissue-based assay which measures expression levels of the Mena protein and its non-invasive isoform Mena11A. The MenaCalc™ diagnostic platform is prognostic for metastatic risk and has the potential to predict outcome in multiple epithelial-based tumor types including breast cancer, prostate cancer, Non-Small Cell Lung Cancer (NSCLC), and colorectal cancer (CRC).
The Mena protein and its isoforms are key potentiators and modulators of cellular phenotype and migration and are central to the metastatic cascade. Overexpression of MenaINV and down regulation of Mena11a in tumor cells correlate with increased metastatic potential. We believe MenaCalc™ predicts outcome and metastatic risk for the majority of invasive breast cancer patients including the HER2-positive and Triple Negative (TNC) subtypes for which there is no viable diagnostic on the market currently.