FDA Logo Link U.S. Food and Drug AdministrationNational Center for Toxicological Research
U.S. Department of Health and Human Services
horizonal rule
Image of Center for Functional Genomics  page banner
The NCTR Center for Functional Genomics was established in 2001 with the following aims: (1) providing NCTR investigators and their collaborators with access to high quality microarray technology for the investigation of biological mechanisms of action underlying the toxicity of products regulated by the FDA, and related fundamental and applied research; (2) facilitating toxicogenomic studies through interactions with statisticians, bioinformaticians, principal investigators, and Center for Functional Genomic scientists; and (3) utilizing advances in genomics to address issues critical to the FDA mission, in particular to the FDA Critical Path Initiative. 

The Center for Functional Genomics uses high information content microarrays in the development of mechanistic and biomarker data for improved safety assessments.  Platforms include (1) in-house fabrication of whole genome oligonucleotide microarrays, (2) in-house printing of custom, targeted microarrays, (3) Agilent whole genome and Comparative Genomic Hybridization microarrays, and (4) Affymetrix expression arrays and whole genome SNP arrays.  Both whole genome commercial arrays and in-house fabricated custom microarrays show great promise in drug safety evaluation, and FDA is actively encouraging this new technology. Major efforts in this area by the Center for Functional Genomics include (1) contributing toward standards and regulatory assessment of this new technology, (2) identifying sources of technical variability in microarray experiments and developing quality assurance/quality control (QA/QC) procedures to help ensure that microarray data submitted to FDA are of sound quality, (3) understanding mechanisms and developing biomarkers, and (4) preparing FDA for genomics submissions by working through the Voluntary Genomics Data Submission (VGDS) process.  Center for Functional Genomic scientists have been involved in the development of RNA proficiency standards with national and international groups, including the Microarray Quality Control (MAQC) project and the External RNA Controls Consortium (ERCC).  In addition, these experiences were used to help develop the Companion Guidance for the FDA Guidance for Industry- Pharmacogenomic Data Submissions.

Recently, a custom gene expression microarray (MitoChip) has been developed for analysis of mitochondrial dysfunction in mouse model systems.  Probes for more than 500 genes involved in the structure and function of the mitochondria were designed and printed onto glass slides.  The MitoChip has proven useful in studies performed to understand the molecular mechanism of mitochondrial dysfunction associated with anti-HIV drugs (AZT, 3TC, and Nevirapine), anti-cancer drugs (cis-platin and flutamide), and a weight-loss dietary supplement (usnic acid).

The Center of Functional Genomics has extensive collaborations with NCTR researchers, other FDA centers, industry, other government agencies, and academic institutions to apply gene expression microarray technologies to facilitate drug safety assessments, food safety evaluation, and improve predictability of drug toxicity for the realization of personalized medicine.

Contact Information

For more information, please contact Dr. James Fuscoe at 870-543-7126 or james.fuscoe@fda.hhs.gov 

horizonal rule