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Gene Logic Provides the FDA with Access to Toxicogenomics Data and Analysis Systems for Reviewing Voluntary Genomic Data Submissions.

GAITHERSBURG, Md. -- Gene Logic Inc. (NASDAQ:GLGC) announced today that it entered into an agreement with the United States Food and Drug Administration ("FDA") to provide the FDA with access to certain of Gene Logic's genomics data and software, including:

--An extensive collection of toxicogenomics and rat classical toxicology data from the ToxExpress(R) System including hundreds of time and dose studies.

--Gene Expression data from thousands of normal human tissue samples from the BioExpress(R) System for comparative analyses.

--The powerful Genesis Enterprise System(R) 3.0 software for data management and analysis and the GX(TM) Connect 3.0 software for uploading third-party data into the Genesis Enterprise System.

These data and software can help the FDA evaluate voluntary genomics data submissions ("VGDS") as outlined in FDA's March 2005 Pharmacogenomics Guidance Document, which encourages the voluntary submission of genomics data--primarily genotyping and gene expression analysis--to help inform the agency of the types of emerging technologies that are being used to identify relevant biomarkers. The data can also assist FDA in its goal to speed the development and approval of medical products as outlined in its 2006 Critical Path Initiative Report and the corresponding Critical Path Opportunities list released March 2006.

Data from the ToxExpress and BioExpress Systems allows the FDA to evaluate VGDS in a single species or across multiple species. Potential candidate biomarkers can also be evaluated for the specific nature of their toxic response and whether they have restricted tissue distribution in normal organ panels.

The Genesis Enterprise System and GX(TM) Connect software can assist FDA to:

--Conduct synchronized analysis of gene expression data with pathology and clinical annotations to assess treatment or disease affects of submitted data

--Provide comparative context across multiple species on potential candidate biomarkers identified in VGDS

--Better understand the mechanisms of toxicity or pathways affected by disease

The large volume of high quality Gene Logic data also gives FDA the ability to determine baseline expression variation for particular genes that can be helpful in advancing certain scientific projects outlined in their Critical Path Initiative. Gene Logic is known for having one of the most extensive repositories of reliable human and animal gene expression data in the world, built on a foundation of strict operational and quality standards, based on experience processing over 180,000 microarrays.

"Gene Logic embraces the opportunity to provide the FDA with reliable solutions that can offer context for reviewing VGDS," said Dr. Donna Mendrick, Gene Logic Fellow and Vice President. "The FDA is receiving sufficient toxicogenomics and toxicology data from Gene Logic to readily provide benchmarks for dose and time responses of drugs known to induce toxicity and control compounds, thereby augmenting their internal capabilities to provide meaning to VGDS."

Gene Logic Overview

Gene Logic technologies and services are used by many of the world's top pharmaceutical and biotechnology companies. Over 150 organizations and government agencies have benefited from Gene Logic's diverse portfolio of drug development services, enabling them to make more informed, more reliable and more predictive decisions at each point in the highly complex and costly drug development process. Founded in 1994, Gene Logic is headquartered in Gaithersburg, Maryland, conducts additional research and development in facilities in Cambridge, Massachusetts, and has customer support operations in the U.S., Europe, and Asia. For more information, visit or call toll-free - 1/800/GENELOGIC.
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Publication:Business Wire
Geographic Code:1USA
Date:Aug 10, 2006
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