Gene Logic, Inc. entered into an agreement with the FDA to provide the FDA with access to certain genomics data and software, including: a collection of toxicogenomics and rat classical toxicology data from the ToxExpress System including time and dose studies, gene expression data from normal human tissue samples from the BioExpress System for comparative analyses, and the Genesis Enterprise System 3.0 software for data management and analysis and the GX Connect 3.0 software for uploading third-party data into the Genesis Enterprise System.

According to Gene Logic, 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.

“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.”