Wyeth Research Expands Regulatory-Compliant Pharmacogenomic Testing Services Agreement With Expression Analysis
Durham, NC - Expression Analysis, Inc. a full-service microarray processing, analysis and data management organization, has expanded its July 2004 agreement to provide contract pharmacogenomics testing services using the Affymetrix GeneChip platform to Wyeth Research, one of the world's largest research-driven pharmaceutical and healthcare products companies. All microarray services provided under this agreement are to be compliant with 21 CFR Part 58 (Good Laboratory Practices) in support of clinical studies.
"We have been very satisfied with the level of expertise, quality and service from Expression Analysis," said Dr. John Ryan, SVP, Translational Research at Wyeth Research. "Expression Analysis has become a valued partner in our pharmacogenomic studies." Added Ryan, "Expression Analysis typifies what we seek in a partner; exceptional expertise in their technology, superior responsiveness and a collaborative attitude."
Steve McPhail, President and CEO of Expression Analysis commented: "We are delighted to expand our agreement with Wyeth Research. Expression Analysis has built its infrastructure to support high volume, regulatory compliant pharmacogenomic services for the pharmaceutical market. This new commitment by Wyeth Research validates our efforts to facilitate the use of this technology in pharmaceutical clinical trials."
Expression Analysis, in collaboration with the CDER and Schering-Plough became the first company to submit electronic microarray data to the FDA in 2003 to assist the Agency in understanding how this data might be used in a regulatory submission. In 2004, Expression Analysis became the first microarray processing laboratory in the world to achieve compliance with Good Laboratory Practice regulations and CLIA registration. These and other collaborative activities, including standardization initiatives and development of expertise in a variety of blood-based protocols, have allowed the company to build its infrastructure to facilitate the use of microarray technology in support of pharmaceutical clinical trials. The company has demonstrated its expertise in other applications as well by completing projects for clients utilizing Affymetrix's new 500K Mapping Arrays and Exon Arrays.
SOURCE: Expression Analysis, Inc.