NEW YORK (360Dx) – MetaStat announced today that it has received California, Florida, Pennsylvania, and Rhode Island licensure for its Boston-based digital pathology laboratory.
The company, which received CLIA certification from the Centers for Medicare and Medicaid Services last year, said it can now accept clinical samples from 48 states.
MetaStat provides tests for breast, lung, colorectal, and prostate cancers including the MetaSite Breast and MenaCalc assays, which stratify patients based on tumor aggressiveness and metastatic risk. Earlier this year, the company’s collaborators presented data showing MetaSite Breast could identify patients at greater risk of distant cancer metastasis who had low recurrence score results with Genomic Health's Oncotype DX.
MetaSite Breast is intended for patients with early-stage invasive breast cancer who have node-negative or node-positive, hormone receptor-positive, HER2-negative disease.
"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," MetaStat President and CEO Douglas Hamilton said in a statement. "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."