Gene Logic Provides the FDA with Access to Toxicogenomics Data and Analysis Systems
Gene Logic Inc. announced 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 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.
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