The laboratory houses dedicated sequencing and gene expression profiling technology as part of the contract research organisation’s (CRO) clinical drug development offering.
The Clinical Laboratory Improvement Amendment (CLIA) certificate is covered by Federal regulations, CFR 42 Part 493.2, designed to ensure consistency of testing in all 200,000 clinical laboratories in country.
However, Covance’s certification was issued by the State of Washington, which is one of only four states to take direct responsibility for administering and managing the CLIA accreditation
John Gransee, VP and general manager of the facility, said the certification underlines that testing conducted at the laboratory is carried out in a manner consistent with the highest standards.
“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.”
This was echoed by Gordon Kapke, Covance’s High Complexity Laboratory Director, who said: “Our team diligently implemented the regulatory standards needed to move from a research lab to a CLIA-certified lab.”
Personalised medicines
The Seattle laboratory was bought for $145m from US drug maker Merck & Co in August 2009 as part of Covance’s efforts to build capacity in the filed personalized medicines discovery and development.
Speaking at the time CEO Joe Herring said: "We recognized the need to expand our footprint in the important and growing genomics testing market and this transaction provided both a superior and quicker entry point than the build or buy options we considered.
He also forecast that: “The overall size of the genomics market is estimated at several hundred million dollars per year, including services for discovery/preclinical and clinical trials support."