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 certification, 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 Sciences
At Epic Sciences, we develop clinically proven predictive tests to detect and monitor cancer at the individual cell level. With a proprietary rare-cell detection engine, we provide insights to clinical, biotech, pharmaceutical and academic teams on how cancer emerges, mutates and remits so they can make pivotal decisions at every point in patient treatment with greater certainty. Recognizing the unique nature of each person’s cancer, we offer truly personalized diagnostic tests, while being non-invasive for the patient.
We have developed the first clinically proven predictive test for metastatic castration-resistant prostrate cancer (mCRPC), the Epic AR-V7 test. Using the same rare-cell detection platform and Epic’s biobank of over 30,000 blood samples, each profiled with predictive biomarkers, we partner with leading pharmaceutical and biotechnology companies, major cancer centers, the National Cancer Institute (NCI), and the National Institutes of Health (NIH) to pursue additional predictive tests for breast, ovarian, colon and other cancers and diseases. Our mission is to revolutionize cancer care and therapies to make them as precise, safe and life-sustaining as humanly possible.
For more information, visit epicsciences.com.
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