Gene Logic to provide FDA with access to toxicogenomics data, analysis systems

By Elaine Rigoli

Tampa, Fla., Aug. 10 - Gene Logic, Inc. has entered into an agreement with the Food and Drug Administration 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 hundreds of time and dose studies; gene-expression data from thousands of normal human tissue samples from the BioExpress system for comparative analyses; 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.

The company said the data and software can help the FDA evaluate voluntary genomics data submissions as outlined in the 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.

"Gene Logic embraces the opportunity to provide the FDA with reliable solutions that can offer context for reviewing voluntary genomics data submissions," vice president Donna Mendrick said in a company news release.

"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 voluntary genomics data submissions."

Headquartered in Gaithersburg, Md., Gene Logic provides technologies and services to pharmaceutical companies.

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