BOSTON, Feb. 8, 2017 /PRNewswire/ – Mitra Biotech, Inc., a global leader in advancing the personalization of cancer treatment, today announced the receipt of Clinical Laboratory Improvement Amendments (CLIA) certification for its Woburn, MA laboratory. CLIA certification denotes high quality standards, ensuring the accuracy, reliability, and timeliness of testing results.
Mitra’s CLIA certification enables the company’s U.S. clinical launch of CANscript™ in early 2017. CANscript is a functional, phenotypic platform that predicts clinical response to physician-selected cancer treatments. The CANscript platform replicates an individual patient’s tumor microenvironment, delivering highly personalized treatment response predictions that correlate strongly with clinical outcomes. CANscript’s powerfully predictive results help inform patient treatment decisions and support more effective drug development.
“We’re very pleased to receive CLIA certification for our Massachusetts laboratory, representing a significant milestone in our introduction of CANscript to the U.S. market,” said Mallikarun Sundaram, president, co-founder, and CEO of Mitra Biotech. “This demonstrates our ongoing dedication to stringent quality standards, and opens the door for CANscript to deliver personalized treatment prediction information to U.S. patients at a critical point in their treatment path, as well as actionable information to drive more effective cancer drug development.”
Mitra’s CLIA certification closely follows the company’s National Accreditation Board for Testing and Calibration Laboratories (NABL) certification of its India facility.
About Mitra Biotech™
Mitra Biotech is a global leader in advancing personalized oncology treatment and supporting more effective and efficient drug development.
Founded in 2010, Mitra is headquartered in Woburn, MA and maintains a significant research and laboratory presence in Bangalore, India. An accomplished leadership team of industry professionals heads the company, with a dedicated focus on enhancing the personalization of cancer treatment and care worldwide.
Mitra’s CANscript is a novel functional platform that replicates an individual patient’s unique tumor microenvironment to predict treatment response. CANscript tests physician-selected treatments, measuring a series of response parameters via multiple terminal and kinetic assays. The platform uses a sophisticated, clinical data-trained algorithm to synthesize the evaluated tumor responses into a single score for each treatment tested, reliably predicting treatment response rates and highlighting less effective treatment options. Test results are available in seven days.
CANscript has been validated using thousands of cancer cases, with a published 90% overall correlation1 between the platform’s treatment predictions and actual clinical outcomes.
Chief Commercial Officer
Mitra Biotech, Inc.