Covance Genomics Lab Gets CLIA Certification

Covance’s genomics lab in Seattle, WA received Clinical Laboratory Improvement Amendment (CLIA) certification from the State of Washington Department of Health. The lab was licensed in May 2010 and completed the initial CLIA inspection, with no findings, in December 2010. Inspections of CLIA labs is mandated by the Code of Federal Regulations (CFR 42 Part 493.2), and was enacted to ensure consistent, accurate, and reliable clinical test result reporting from laboratories across the country.

The lab supports 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.

In addition to performing CLIA-regulated services, the genomics laboratory meets GLP requirements, having performed multiple GLP protocols and undergone subsequent GLP audits from pharmaceutical clients.

“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.”