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FOR IMMEDIATE RELEASE
Contact:
Steve McPhail
919-405-2248
smcphail@expressionanalysis.com
Expression Analysis, Inc., Becomes First Company Capable of Providing Affymetrix GeneChip® Processes in Compliance with Good Laboratory Practices
Durham, N.C., (May 25, 2004)—Expression Analysis, Inc., a full-service microarray genetics testing, analysis and data management organization, today announced the completion of requirements and internal audits associated with GLP good laboratory practice (GLP) regulations as detailed in 21 CFR Part 58, making it the first company capable of providing Affymetrix GeneChip® processes performed in compliance with GLP regulations. To meet these requirements, the company has developed and implemented controls applicable to sample processing, i.e. standard operating procedures (SOP's), equipment and process validations, training, audits and document control measures .
Expression Analysis recently collaborated with the FDA to assist the agency with developing guidelines on the format, content and context of microarray data in regulatory submissions.
“To meet the requirements outlined in 21 CFR Part 58 was a logical next step for us,” said Steve McPhail , Expression Analysis' CEO. “We are now one step closer to our goal of facilitating the use of microarray-based genomic technologies in the drug development process.”
Compliance with these regulations is necessary to include microarray-based, gene-expression data with non-clinical laboratory studies that are intended to support research applications or marketing permits for FDA-regulated products .
“We believe that use of genomic technologies in preclinical and clinical trials may lead to significant improvements in healthcare delivery and human health,” said McPhail.
“Since our inception, quality and customer service have been our primary objectives,” says Steven Casey, Expression Analysis ' Chief Operating Officer. “ Meeting the GLP requirements took more than two years but was based on a solid foundation of documentation and validation that we already had in place. We look forward to providing these value-added services to our growing base of clients.
About Expression Analysis
Expression Analysis, Inc., (EA) (www.expressionanalysis.com) is a full-service microarray genomics testing and analysis organization dedicated to providing clients with the highest quality genomic processing and data analysis services using Affymetrix GeneChip® brand technology. In 2004, EA became the first microarray services facility, worldwide, to provide GLP-compliant services. EA is a U.S.-based authorized service provider for Affymetrix (www.affymetrix.com), a California-based company that develops and commercializes systems to help researchers explore the relationship between genes and human health.
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