Gene Logic Collaborates With FDA to Explore Genomic Data Quality Metrics Related to Drug Candidate Safety and Effectiveness

Gene Logic Inc. (NASDAQ:GLGC) announced today that it has entered into a collaboration with the United States Food and Drug Administration (FDA) to share quality control methods and metrics that may be useful in better understanding disparate genomic data sent as part of regulatory submissions. The collaboration is part of the FDA’s Critical Path Initiative, an effort to stimulate and facilitate the use of new scientific and technical methods–such as computer-based predictive models and biomarkers for safety and effectiveness–intended to improve the predictability and efficiency of drug development from laboratory concept to commercially approved medicines. The results of the collaboration will be released publicly as an early step towards formulating industry-wide standards for genomic data assessment. There are currently no federal or industry standards in place for assessment of the quality of genomic data submissions to the FDA.

Gene Logic is well known in the pharmaceutical and biotechnology industry as a pioneer and quality leader in obtaining and analyzing genomic data, having assembled one of the world’s largest and most detailed knowledge bases of gene expression profiles from human tissues and cells. The Company has processed more than 200,000 microarrays to obtain genomic data and has developed proprietary methods and software to ensure those data are accurate, including more than 40 quality metrics.

Donna Mendrick, Ph.D., Gene Logic Scientific Fellow and Vice President of Toxicogenomics, said, “Industry and FDA consensus is that biomarkers are valuable tools for assessing the safety and efficacy of drug candidates. This collaboration between Gene Logic and the FDA is a step on the path to achieving a common understanding of key microarray QC procedures that may lead to the development of preliminary microarray data standards for the submission of microarray data to the FDA.”

A senior FDA official has commented that, “currently there are no industry standards in place for microarray data submission to the FDA, and projects focused on understanding the QC issues will help drive the development of baseline standards for the submission of microarray data to the FDA in the future.”

Gene Logic Genomics Overview

Gene Logic has developed proprietary genomics databases and services to enable customers worldwide to discover and prioritize drug targets, identify biomarkers, predict toxicity and understand mechanisms of toxicity, and obtain insights into the efficacy of specific compounds.

Founded in 1994, Gene Logic is headquartered in Gaithersburg, Maryland, with additional research and development facilities in Cambridge, Massachusetts. The Company currently has about 150 employees worldwide. For more information, visit www.genelogic.com or call toll-free — 1/800/GENELOGIC.