Covance Genomics Lab Receives CLIA Certification

Covance, like Charles River, Quintiles, and other similar companies, is a contract research organization (CRO). It manages various aspects of research projects such as clinical trials for pharmaceutical companies. In this regard, Covance is a major provider of lab testing for such trials and has developed a global lab network to facilitate the exchange and analysis of such data (see: Covance's Execution of a Global Virtual Clinical Lab). Quintiles has also established itself as a global lab presence (see: Quintiles Promotes Its "Globally Harmonized" Lab Network). These companies are thriving as Big Pharma downsizes and turfs more business to its CRO partners (see: CROs Continue to Prosper; Benefits of Big Pharma Outsourcing). Covance recently announced that it has received CLIA certification for its genomics laboratory (see: Covance Genomics Laboratory Receives CLIA Certification).  Below is an excerpt from the article:

Covance ...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 has performed multiple GLP protocols and undergone subsequent GLP audits from pharmaceutical-based clients. 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....The [CLIA] 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.

An interesting question is why a CRO such as Covance, with its focus on clinical research, would seek CLIA certification for its genomic laboratory. Phase II, III, and IV clinical trials involve human subjects who suffer from the disease being studied in the trials. Increasingly, molecular diagnostic tests are a critical component of such studies.The CRO works on a contractual basis with the pharmaceutical company sponsor of such trials and there is usually no obligation, or even intention, to share the test results with the study subjects. This is not to say that the these test results are inaccurate if and when generated in a non-CLIA-certified lab. It just seems that the step of CLIA accreditation is perhaps unnecessary for a CRO lab.

It may be the case that seeking CLIA certification is an important step by the company in its overall QC program to assure its pharmaceutical clients that its lab services are of the highest quality. Another possibility is that, during a clinical trial, the sponsor chooses to share the molecular diagnostic studies performed during the process of the study with both the subjects and their treating physicians. This becomes less problematic from a clinical care delivery perspective if the test-performing lab is CLIA-certified.

Comments

[Theo]

Isn't this similar to IVD manufacturers and pharma companies setting up or acquiring a CLIA lab? i.e., Novartis/Genoptix or Celera/Berkeley? A CLIA lab enables vertical integration. In the case of a CRO, the identical assay that is used throughout the trial can now be assured of availability post launch. For a pharma company with a drug/diagnostic combination - getting ready to launch without that particular assay having wide, or any availability - is a stumbling block to success.