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MetaStat Announces Successful Analytical Validation of its MenaCalc™ Cancer Diagnostic Platform
MetaStat Announces Successful Analytical Validation of its MenaCalc™ Cancer Diagnostic Platform.
About this update from Metastat Inc
[{"type":"text","content":"\n \n MetaStat, Inc. (OTCQB: MTST), a molecular diagnostic company, today \n announced the successful completion of an analytical validation study of \n its MenaCalc™ clinical test, which demonstrated strong overall assay \n performance and precision with mean coefficient of variation (%CV) of \n only 2.3% (Range 0.07-6.95). MenaCalc™ is a next generation driver-based \n prognostic test to predict the risk of developing cancer metastasis in \n patients with invasive breast cancer, squamous cell carcinoma of the \n lung and a number of additional epithelial-based cancer tumors. The \n MenaCalc™ results, reported as a MenaCalc™ Score, better inform \n physicians in making treatment decisions to enhance outcomes.\n \n \n “With successful analytical validation we are now advancing into our \n clinical validation studies with confidence,” stated Mark Gustavson, \n PhD, Vice President Diagnostics of MetaStat. “Analytical precision is a \n prerequisite for clinical accuracy.”\n \n \n In this study, MetaStat assessed the overall assay performance, imaging, \n and scoring performance of the fully-automated quantitative \n immunofluorescence clinical MenaCalc™ test using FFPE tissue samples \n (n=28) from patients with invasive breast cancer. MenaCalc™ was shown to \n have strong assay performance (day-to-day reproducibility) as measured \n by linear regression analysis showing Pearson’s R greater than 0.85 and \n linear slopes greater than 0.98 with a mean %CV of 2.3% (Range \n 0.07-6.95). Further, imaging and scoring performance (run-to-run \n precision) was also highly precise with Pearson’s R and linear slopes \n greater than 0.99 as well as %CV of 0.45% (Range 0.02-2.32).\n \n \n “Findings published online, in BMC Cancer in June 2015, \n demonstrated the value of MenaCalc™ as a prognostic marker for survival \n in patients with node-negative invasive breast cancer,” stated Douglas \n A. Hamilton, President and CEO of MetaStat. “We are excited and look \n forward to providing physicians with commercial access to our MenaCalc™ \n test later this year, after we complete our clinical validation program. \n Data from the clinical program will support physicians’ decision to use \n the test and payors to reimburse for it.”\n \n...