MetaStat, a pre-commercial biotechnology company, announced that it has received California, Florida, Pennsylvania, and Rhode Island state licensure for its next-generation digital pathology laboratory in Boston, Massachusetts.
These state certifications follow receipt of CLIA certification from U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) that now allow MetaStat to accept clinical samples from 48 states.
Douglas A. Hamilton, MetaStat’s President and Chief Executive Officer stated “Receiving these state licenses coupled with our recently announced positive analytical and clinical validation studies for the MetaSite Breast™ test are important steps towards commercialization.”
Results from a clinical study led by ECOG-ACRIN Cancer Research Group, presented at the 39th San Antonio Breast Cancer Symposium (SABCS) in December 2016, found the MetaSite Breast test was able to identify patients at greater risk of distant cancer metastasis who had low Oncotype DX Recurrence Score results.
Results from a Kaiser Permanente Cohort Study demonstrated MetaSite Breast™ score was a statically significant predictor of distant metastasis and a binary cutpoint was able to discriminate high and low risk patient groups.
Mr. Hamilton continued “MetaStat plans to build on these positive data and evaluate MetaSite Breast in additional studies to demonstrate that it can add complementary prognostic information to multiparameter gene panel assays. Expanding our clinical state licenses is an exciting step forward.”
CMS regulates all clinical laboratory testing at over 254,000 sites in U.S. through the Clinical Laboratory Improvement Amendments (CLIA) of 1988. This regulation was enacted to ensure consistent, accurate and reliable test results reporting from clinical laboratories across the country used for the diagnosis, treatment, and/or prognosis of disease in human subjects.
The MetaSite Breast test is intended for use in patients with early stage invasive breast cancer who have node-negative or node-positive, Hormone Receptor (HR)-positive, HER2-negative disease. Clinical studies have demonstrated the MetaSite score (MS) is significantly associated with increased risk of cancer metastasis.
MetaSite Breast is an analytically validated, fully automated digital pathology/image analysis assay that identifies Mena expressing tumor cells in direct contact with CD68+ perivascular macrophages and CD31+ endothelial cells (“MetaSites”).
MetaSites have been shown to be the portal of entry for cancer cells into the blood stream contributing to the development of cancer metastasis.