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FOR IMMEDIATE RELEASE

Contact:
Jim Parina
724-935-7029
jparina@expressionanalysis.com


Covance and Expression Analysis Team to Provide Genomic Microarray Testing Services for Clinical Trials

Indianapolis, IN- March 23, 2005- Covance Inc. (NYSE: CVD) a leading global drug development services firm and Expression Analysis (EA), Inc., the leading provider of genomic microarray testing and analysis services, today announced the availability of a first-of-its-kind genomics testing service. Through an agreement with Expression Analysis, Covance’s Central Laboratory Services unit, the world’s largest clinical trial laboratory services provider, will offer genomic microarray testing as an integral part of their clinical trial services. The agreement combines Covance’s global Central Laboratory clinical trials capabilities with Expression Analysis’ pharmacogenomic microarray testing and statistical expertise to enable pharmaceutical and biotechnology firms to conduct genomic microarray testing for patients anywhere in the world.

“Genomic microarray testing technology has the potential to accelerate drug development by enabling pharmaceutical companies to study how patients’ individual genetic makeup affects the body’s response to a particular drug,” said Steve McPhail, President & CEO of Expression Analysis. “In a clinical trial, for example, it may help to define sets of genes or ‘biomarkers’ that may be indicative of the population of patients that will respond most effectively to a new drug. By providing more effective and targeted therapies for patients, it may be possible for genomic microarray testing to reduce the time and cost of clinical trials.”

Recent United States Food and Drug Administration (FDA) guidance (http://www.fda.gov/cder/guidance/6400fnl.pdf) indicates that genomic data may become a necessary component for regulatory submissions in the drug development process. “With the increasing FDA focus on the value of genomic data for evaluating drug submissions, genomic microarray testing is fast becoming a critical element of every biopharmaceutical’s clinical trial strategy,” said Gordon Kapke, Ph.D., Vice President Global Technical Affairs of Covance Central Laboratory Services. “With this in mind, the combination of Covance’s global clinical trial capabilities with Expression Analysis’ scientific and industry leadership gives biopharmaceutical firms the assurance of an efficient, high-value approach.”

he FDA guidance was supported by leaders from the biopharmaceutical industry. "The FDA's guidance on voluntary submission of pharmacogenomic microarray test data promises a win-win for both patients and the pharmaceutical industry," said Andrew Dorner, Ph.D., Senior Director,
Molecular Profiling and Biomarker Discovery at Wyeth Research. "Microarray testing may have the potential to not only help us in the clinic – to identify the right drug for the right patient, at the right dose – but also in the laboratory, to streamline drug discovery by avoiding compound dead-ends and increasing our confidence that drugs that enter clinical testing will have the expected effects". Wyeth Research was the first pharmaceutical company to file pharmacogenomic data with the FDA in February 2004 under the voluntary submission guidance.

Expression Analysis is the world’s first company capable of producing microarray results that are compliant with the Good Laboratory Practices required for pre-clinical regulatory submissions. The company has also collaborated with the FDA to assist the agency in understanding how genomic microarray data might be used in regulatory submissions.

About Covance
Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with annual revenues greater than $1 billion, global operations in 17 countries, and approximately 6,700 employees worldwide. Information on Covance's products and services, recent press releases, and SEC filings can be obtained through its website at www.covance.com.

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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