Covance Genomics Laboratory Receives CLIA Certification
Princeton, N.J., January 20, 2011 — Covance Inc. (NYSE: CVD) today announced its genomics laboratory, located in Seattle, Washington, has received Clinical Laboratory Improvement Amendment (CLIA) certification from the State of Washington Department of Health. The laboratory received its license from the State of Washington in May 2010, and completed the initial CLIA inspection, with no findings, in December 2010.
“Obtaining CLIA certification demonstrates to our clients that our laboratory is consistently performing at a very high standard in a regulated environment,” said John Gransee, Vice President and General Manager, Covance Genomics Laboratory. “This is particularly important when a researcher wants to use the data in discovery to develop a clinical assay. In addition, since every test performed in our laboratory is under the CLIA umbrella, our clients can be confident that they are receiving high quality execution of their experiments regardless of analysis platform.”
In addition to performing CLIA-regulated services, Covance’s genomics laboratory has successfully tailored its quality standards to meet GLP requirements. The laboratory has performed multiple GLP protocols and undergone subsequent GLP audits from pharmaceutical-based clients.
“Our team diligently implemented the regulatory standards needed to move from a research lab to a CLIA-certified lab,” said Gordon Kapke, Ph.D., DABCC, High Complexity Laboratory Director, Covance Genomics Laboratory. “One of the new features of which we are most proud is the new paperless electronic system that allows for error-free tracking of patient samples, documents, equipment, and data.”
Covance Genomics Laboratory, acquired in August 2009 from Merck, recently celebrated 10 years of supporting drug discovery and development work since its inception as part of Rosetta Inpharmatics. The laboratory is purpose-built to support genomics-based drug development with services including: next generation sequencing, gene expression profiling, genome-wide genotyping, qPCR biomarker assays, microRNA profiling, targeted genotyping, tissue homogenization and nucleic acid extraction, scalable amplification protocols and computational biology & bioinformatics. Having run more than 450,000 samples to date, the laboratory provides end-to-end services for genomics-based drug development research.
Mandated by the Code of Federal Regulations (CFR 42 Part 493.2), the Centers for Medicare & Medicaid Services (CMS) manage and conduct inspections of CLIA laboratories. The regulation was enacted to ensure consistent, accurate, and reliable clinical test result reporting from laboratories across the country used for the diagnosis, treatment, and/or prognosis of disease in human subjects. CLIA applies to all clinical laboratories operating in the United States and its territories and encompasses more than 200,000 clinical testing sites; the State of Washington is one of four exempt states and manages CLIA laboratories within Washington.