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Clinical Data Plays Integral Role in MicroArray Quality Control Consortium Project

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Cogenics, a division of Clinical Data Inc. and comprised of the combined companies of Genaissance Pharmaceuticals, Lark (US and UK), Icoria, and Genome Express of France, have joined with other participants of the MicroArray Quality Control (MAQC) Consortium in publishing the results of the FDA-led initiative to assess the precision, reproducibility and comparability of microarray gene expression data.

Cogenics contribution was unique in the generation and analysis of multi-platform gene expression data and resulted in three publications in the September 2006 issue of Nature Biotechnology.

"The MAQC project represents a key step towards establishing the use of microarrays in the discovery, development and review of FDA-regulated products," said Robert Bondaryk, PhD, General Manager of Cogenics.

"The success of these efforts distinguishes Cogenics from the few gene expression services providers focused on data production within an FDA-regulated environment."

"The ability to provide these services for a significant number of major companies is a testimony to Cogenics' years of experience, know-how and leadership position in this area."

The completion of the MAQC project represents a milestone toward FDA's "Critical Path Initiative," which identifies pharmacogenomics and toxicogenomics as key opportunities in advancing medical product development and personalized medicine.

This project involved the combined efforts of government and academic laboratories, providers of RNA samples and gene expression platforms, and gene expression service providers.

The aim of the MAQC project has been to establish quality metrics and guidelines for data analysis for the scientific community.

This work has generated a large, publicly-available data set that demonstrates the reproducibility of gene expression data obtained from microarrays, and provides a resource to the larger scientific community to evaluate and assess the quality of their own data and procedures.

Bondaryk continued, "We are pleased to participate in the community-wide 'standardization' initiatives to advance the use of microarray data for research and regulatory submissions, including the current FDA-initiated project and other ongoing efforts with the NIEHS Toxicogenomics Research Consortium."

"We are very proud of our extensive experience with multiple gene expression profiling platforms and long history of performing complex gene expression studies for pharmaceutical and biotechnology companies, as well as for government and academic researchers in the life science community."

"The success of the MicroArray Quality Control Project ensures that these technologies will continue to play a critical role in biological research globally and in the new drug approval process."