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FOR IMMEDIATE RELEASE
Contact:
Jim Parina
724-935-7029
jparina@expressionanalysis.com
Expression Analysis Submits Microarray-Based Gene Expression Data to the Food and Drug Administration
Durham, N.C. (Sept. 8, 2003) - Expression Analysis, Inc., a full-service microarray genetics testing, analysis and data management organization, has completed a significant milestone in a "mock-submission of microarray data" being prepared for the Food and Drug Administration (FDA).
Using data from a toxicology study conducted by Schering-Plough Corporation, Expression Analysis provided a "pilot" XML-based submission of microarray gene expression data and associated results to the FDA. These data will be used to assist the FDA in development of guidance on the format, content and context of microarray data in regulatory submissions.
"Our initial pilot submission contained information on laboratory and informatics infrastructure, RNA standards, biological and processing factors, data analysis methods and data documentation," said Steve McPhail, CEO of Expression Analysis. "We will now begin a series of detailed discussions with the FDA to refine these sections of the submission and, working closely with Schering-Plough, we will incorporate other toxicology results and the interpretation the toxicogenomic data set."
Expression Analysis, the leading U.S.-based authorized service provider for Affymetrix GeneChip® microarray technology, is using Affymetrix's MAS 5.0 software and other data analysis methods to analyze the data in this project. The company is also working closely with Constella Biomedical Informatics, a division of the Constella Group, Inc.; a Durham, N.C.-based professional human health organization, to manage linkage of microarray data with other data sets including clinical chemistry, histology and phenotype information.
Expression Analysis plans to utilize the knowledge gained in this project to offer microarray processing, analysis and data management services to pharmaceutical, biotechnology and diagnostic companies that require microarray data generation for regulatory submissions.
"Upon completion of this project in early November, Expression Analysis will be the first company to have provided the FDA with an electronic submission containing microarray data," stated McPhail. "We are delighted to take a leadership role in assisting industry and the FDA in the development of regulatory benchmarks for microarray-based gene expression data. This type of data has the potential to play an important role in the future of drug development. We believe that completion of this project and compliance with additional regulatory initiatives (21 CFR Part 58 - GLP and 21 CFR Part 11 - Electronic Records and Signatures) will provide significant value to our customers."
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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