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 ( www.fda.gov/bbs/topics/news/2005/NEW01167.html ) 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."
The 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.
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 18 countries, and approximately 6,700 employees worldwide. Information on Covance's products and services, recent press releases , and SEC filings can be obtained through the Covance website.
About Expression Analysis Expression Analysis ( www.expressionanalysis.com ), based in Durham, North Carolina is a full-service microarray genetics testing and analysis company dedicated to providing clients with high-quality genomic processing and data analysis services using Affymetrix GeneChip® microarray technology. This technology applies the principles of semiconductor technology to the 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. Founded on the expertise of investigators at Duke University and the Duke University Medical Center, 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.
Statements contained in this press release, which are not historical facts, are forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All such forward-looking statements including the statements contained herein regarding anticipated trends in the Company's business are based largely on management's expectations and are subject to an qualified by risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, competitive factors, outsourcing trends in the pharmaceutical industry, the Company's ability to continue to attract and retain qualified personnel, the fixed price nature of contracts or the loss of large contracts, and other factors described in the Company's filings with the Securities and Exchange Commission.