Jan 26, 2005 Expression Analysis to Provide Regulatory-Compliant Microarray-Based Genomic Data for Immune Tolerance Network's Clinical Trials
Durham, NC – January 25, 2005 – Expression Analysis, Inc. (EA) has been selected to serve as the microarray core facility to support clinical trials for the Immune Tolerance Network (ITN), an international collaborative research effort involving more than 70 leading laboratory scientists, clinical professionals and other technical experts.
Founded in Durham in 2001, EA is the industry’s leading provider of regulatory compliant Affymetrix GeneChip® processing services for clinical trials. EA offers high-throughput sample processing and statistical support for microarray-based gene-expression, genotyping and resequencing.
Over a 20-month renewable contract beginning now, EA will provide the ITN with a single-source environment for processing clinical trials samples submitted from multiple locations. EA expects to process several thousand clinical samples during the initial contract period.
“We are pleased to have the opportunity to support the ITN’s extensive research efforts in transplantation, autoimmune diseases, allergy and asthma,” said EA President and CEO Steve McPhail. “The ITN is currently planning, developing and operating several clinical trials, and our involvement in these studies will provide it with exceptional genomic data developed in a regulatory-compliant (GLP) environment.”
EA has been instrumental in helping to establish processes and procedures necessary for the inclusion of gene-expression based data in clinical trials. EA collaborated with the FDA to assist the agency in understanding how genomic data might be used in regulatory submissions. It also was the first Affymetrix microarray service provider in the world to achieve compliance with 21CFR Part 58, Good Laboratory Practices. The company expects to achieve Clinical Laboratory Improvement Act/Amendment (CLIA) certification to support potential microarray-based clinical diagnostic testing in the first quarter of 2005.
“The ITN faces numerous challenges in the collection and analysis of microarray data due to its multi-trial environment and diverse research platform,” said Vicki Seyfert, ITN executive director of tolerance assays and data analysis. “We are looking forward to working with the team at Expression Analysis to help us meet these challenges.”
The Immune Tolerance Network is an international research collaboration that aims to accelerate the clinical development of tolerance therapies through novel clinical trials and parallel mechanistic studies. The ITN is planning, developing and operating 20 clinical trials in autoimmune diseases, islet, kidney and liver transplantation, and allergy and asthma and operates a dozen core facilities that support these studies with state-of-the-art bioassay services. Headquartered at the University of California, San Francisco, with offices in Bethesda, Md., and Pittsburgh, Penn., the ITN is supported by the National Institute for Allergy and Infectious Diseases, the National Institute for Diabetes and Digestive and Kidney Diseases and the Juvenile Diabetes Research Foundation. For more information, visit www.immunetolerance.org.
About Expression Analysis
EA (www.expressionanalysis.com) is a full-service microarray genetics testing and analysis organization dedicated to providing clients with the highest quality genomic processing and data analysis services using Affymetrix GeneChip® brand technology. This technology applies the principles of semiconductor technology to life sciences, making it possible to qualitatively and quantitatively measure gene expression levels in a number of biologically relevant organisms, quickly and with more reliable results. EA is one of the few U.S.-based authorized service providers 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.
Media Contact:
Katherine Smart
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E-mail:ksmart@constellagroup.com