We can now participate in a greater variety of therapeutic clinical trials to provide molecular information about the disease status and therapeutic response of a patient at each clinical decision point.
HAYWARD, Calif. (PRWEB) July 16, 2018
Predicine, a molecular information company based in Silicon Valley, announced today that the company has received certification from the U.S. Department of Health and Human Services' Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 for its genomic sequencing laboratory in Hayward, California. This certification, following receipt of a California State license, allows the company to process clinical samples from most U.S states.
“CLIA certification is a critical step that enables us to work with liquid and tissue biopsy samples while we scale for full commercial launch this year. We can now participate in a greater variety of therapeutic clinical trials to provide molecular information about the disease status and therapeutic response of a patient at each clinical decision point,” said Dr. Shidong Jia, Founder and CEO of Predicine. “Now we also partner with pharma clients in companion diagnostic development.”
The CLIA regulations include federal standards applicable to all U.S. facilities that test human specimens for health assessment or to diagnose, prevent, or treat disease. CMS regulates this testing in the United States through CLIA. The Centers for Disease Control and Prevention (CDC), in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality.
Predicine specializes in genomic profiling assays and is dedicated to transforming patient care and clinical drug development. Predicine has developed "GeneRADAR", the industry's first ctRNA + ctDNA liquid biopsy test, to provide a comprehensive understanding of the molecular changes in cancer. Predicine has initiated a patient enrollment program "Predi-Trial" to accelerate global clinical trials through biomarker-driven precision enrollment. The GeneRADAR technology and its biomarker database identify the molecular alterations in a patient's cancer and match the patient with relevant targeted therapies, immunotherapies, and clinical trials. Through its CLIA laboratory in Hayward, CA and facility in Shanghai, Predicine partners with biopharmaceutical companies to support global clinical trials in China, U.S., Europe, APAC and Australia.