Investors

Company News

MetaStat Announces Successful Analytical Validation of its MetaSite Breast™ Cancer Diagnostic

Download PDF

Positive Results Help Solidify Company’s Pathway to Commercializing the Next Generation of Prognostic Tests for Breast Cancer

BOSTON-- MetaStat, Inc. (OTCQB:MTST), a molecular diagnostic company, today 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.

“The successful completion of this study is an essential step in the process for Massachusetts state and CLIA laboratory certification,” stated Olga Pozdnyakova, MD, PhD, Laboratory Director at MetaStat.

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 (%CV) 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.

Driven by bioscience innovation, the treatment of cancer is undergoing a significant evolution toward treating patients based on specific drivers of their disease. MetaSite Breast™ was found to be highly reproducible, with a level of performance and precision required for the exacting standards of clinical practice. “Successful completion of the MetaSite Breast™ analytical validation study marks a significant risk-reduction milestone for MetaStat,” stated Douglas A. Hamilton, President and Chief Executive Officer of MetaStat, “With the automated commercial process now analytically validated, we can move forward to generate additional evidence from clinical validation and utility studies in support of our anticipated product launch in 2016.”

About MetaStat, Inc.

MetaStat, Inc. (MTST) is a molecular diagnostic company that develops and commercializes diagnostic tests for early and reliable prediction of systemic metastasis, the process by which cancer spreads from a primary tumor through the bloodstream to other areas of the body. MetaStat is focused on breast, prostate, lung and colorectal cancers, where systemic metastasis is responsible for approximately 90% of all deaths. The company's function-based diagnostic platform technology is based on the identification and understanding of the pivotal role of the Mena protein and its isoforms, a common pathway for the development of systemic metastatic disease in all epithelial-based solid tumors. Both the MetaSite Breast™ and MenaCalc™ assays are designed to accurately stratify patients based on their individual risk of metastasis and to provide physicians with clinically actionable information to better "customize" cancer treatment. MetaStat's testing platform improves treatment planning decisions by positively identifying patients with a high-risk of metastasis who need aggressive therapy and by sparing patients with a low-risk of metastasis from the harmful side effects and expense of chemotherapy. The company is based in Boston, MA.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the company's Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the company undertakes no obligation to update such statements.

Investors:
MetaStat, Inc.
Rick Pierce, 617-531-0874
Rpierce@metastat.com

Source: MetaStat, Inc.