Print 08 January 2015
SAN DIEGO – January 8, 2015 – Epic Sciences announced today that the company has received certification under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Under the “deemed status” provision of the U.S. Department of Health and Human Services’ (HHS) Center for Medicare and Medicaid Services (CMS), the state of California has granted the company’s initial CLIA clinical laboratory license.
“With the recent move to our expanded facility in San Diego and this initial CLIA license, we have executed on our next growth phase and continued our commitment to quality laboratory testing to provide accurate, reliable and timely test results. We can now accept clinical samples from 46 states, in addition to accepting clinical samples in Europe and Asia through our LabCorp collaboration,” said Murali Prahalad, Ph.D., president and CEO of Epic Sciences.
Dr. Prahalad added, “Furthermore, Epic can now participate in a greater variety of therapeutic clinical trials as a companion diagnostic partner. We look forward to delivering insights and information about the disease status and therapeutic response of a patient’s cancer across each clinical decision point through participation in all stages of drug clinical studies, including interventional trials.”
The CLIA regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CMS regulates this testing in the United States through the CLIA. The Centers for Disease Control and Prevention (CDC), in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality.
About Epic SciencesEpic Sciences, Inc. is developing novel diagnostics to personalize and advance the treatment and management of cancer. Epic’s mission is to enable the rapid and non--‐invasive detection of genetic and molecular changes in cancer throughout a patient’s journey. The company was founded on a powerful platform to identify and characterize rare cells, including circulating tumor cells (CTCs). Epic’s no cell left behind™ technology helps match patients to targeted therapies and monitor for drug resistance, so that the best treatment path can be chosen at every clinical decision point. Today, we partner with leading pharmaceutical companies and major cancer centers around the world. Epic’s goal is to commercialize our technology to increase the success rate of cancer drugs in clinical trials and improve patient outcomes by providing physicians real-time information to guide treatment choices.
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