Assembly of Personal Genomes for Precision Medicine

Scientists from FDA's NCTR and Center for Biologics Evaluation and Research published a review article inPharmaceutics that discusses issues surrounding the assembly of personal genomes to support precision medicine.

The review article provides an overview of human-genome sequencing technologies, genome-assembly software packages, and IT requirements. The article also proposes metrics and parameters for quality assessment of the assembled genomes. Finally, the authors discuss the potential benefits of using personal genomes as references in precision-medicine applications rather than the current public-reference genome derived from multiple individuals.

For additional information, please contact Wenming Xiao, Staff Fellow, Division of Bioinformatics and Biostatistics, FDA/NCTR.

Evaluation of Bisphenol A (BPA) Internal Dose in "High Risk" Populations

Investigators from Pacific Northwest National Laboratory, Oregon State University, and NCTR evaluated a group of pregnant women under closely controlled clinical conditions, including some with the potential for high exposure to BPA. No differences in internal dose were found when comparing either women handling cash-register receipts or women reporting above-average consumption of canned foods (canned food liners contain BPA) with other groups.

The investigators concluded from the controlled collection and the analysis protocols used, that internal BPA exposures in typical pregnant women from both home and clinical settings reflect exposures representative of the general population — (i.e., picomolar or below limits of detection) as previously determined in large national surveys. A manuscript describing this study is now available online at Food and Chemical Toxicology .

For additional information, please contact, Daniel Doerge, Ph.D., Division of Biochemical Toxicology, FDA/NCTR.

National Institutes of Health (NIH) Tobacco Regulatory Science Conference

NCTR scientists presented results from tobacco research projects at the NIH Tobacco Regulatory Science Conference held on the NIH Campus in Bethesda, MD on May 16-18, 2016. The topics of the presentations included:

predictive models for abuse liability
tobacco-induced toxicity in in vitrocardiomyocytes and in 3D human-airway culture models
bacterial populations and tobacco-specific nitrosamines in smokeless tobacco products
impacts of smokeless tobacco products on the oral microbiome.

These research projects were developed in collaboration with and funded by FDA's Center for Tobacco Products.

For additional information, please contact Bradley Schnackenberg, Ph.D., Office of Research, FDA/NCTR.