Genetic Toxicology Article Selected as Editor's Choice

A scientist from NCTR coauthored a research article titled “Derivation of Point of Departure (PoD) Estimates in Genetic Toxicology Studies and Their Potential Applications in Risk Assessment." The article was selected as the Editor's Choice and will be highlighted in an upcoming issue of Environmental and Molecular Mutagenesis. The article reports the results of a study conducted by the HESI/ILSI Genetic Toxicology Technical Committee (GTTC) Quantitative Analysis Workgroup (QAW). The study's goal was to establish guidelines for the use of quantitative analyses of genetic toxicology dose-response data and PoD metrics to improve risk assessments of chemical exposures. NCTR scientists are members of the GTTC QAW.

For additional information, please contact Robert Heflich, Ph.D., Division of Genetic and Molecular Toxicology, FD

Improving Neural Pathological Assessment Using MRI Targeting

Center for Drug Evaluation and Research and NCTR investigators used 10 classical neurotoxicants to test the ability of magnetic resonance imaging (MRI) technology to both detect and follow the course of events observed under traditional pathology evaluation. The MRI can provide the equivalent of 64 planar “slices” of the brain (the estimated number for traditional neuropathology evaluation) “instantly” to the pathologist for targeting regions of interest for further evaluations. The non-invasive MRI technology further permits each animal to be followed longitudinally to evaluate the inception, apex, and regression of lesions of interest. Full-brain MRI imaging offers the potential to dramatically improve detection of neurotoxicity produced by new drugs and facilitate new drug development and evaluations.

For additional information, the manuscript is available online at Regulatory Toxicology and Pharmacology or contact Joseph Hanig, Ph.D., FDA/CDER or Serguei Liachenko, Ph.D., Division of Neurotoxicology, FDA/NCTR.

Global Summit on Regulatory Science (GSRS15)

Focus on Bioinformatic Approaches for Regulatory Science

DATE: October 12-13, 2015

LOCATION: Parma, Italy

For additional information contact:roben.brooks@fda.hhs.gov

RNA Sequencing Quality Control

The Sequencing Quality Control (SEQC) Consortium completed assessment of next-generation sequencing technology (RNA-seq) and has resulted in eight publications, all of which are now available in a Nature Collections special issue. The SEQC was an FDA-led, community-wide consortium consisting of 180 participants from 73 organizations which:

evaluated the technical reliability of RNA-seq
compared RNA-seq to microarray technology
examined how various bioinformatics approaches impact downstream biological interpretations of RNA-seq results
assessed the utility of RNA-seq in clinical application and safety evaluation

For additional information, please contact Weida Tong, Ph.D., Director, Division of Bioinformatics and Biostatistics, FDA/NCTR.