FDA and Big Data: increased surveillance through GenomeTrakr Database & Sentinel Initiative

GenomeTrackr Database

Through collaboration with federal and state public health laboratories, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Regulatory Affairs (ORA) have been building a publicly accessible genomic database called GenomeTrakr.

This database uses Whole Genome Sequencing (WGS) technology to 1) identify pathogens isolated from food or environmental samples, 2) compare those pathogens to the bacterial pathogens isolated from sick patients, and 3) trace the bacterial pathogens back to their sources faster and more precisely than traditional methods.

“Used by epidemiologists in combination with traditional methods, WGS is advancing our understanding of contaminations in the food supply,” according to Dr. Alice Welch, PhD, Director of the FDA’s Technology Transfer Program shared. The GenomeTrakr can help a public health official to “determine which ingredient in a multi-ingredient food is causing the outbreak—so that we can get contaminated food out of the food supply.”

For example, Dr. Welch stated that “In early 2014, through a partnership with CDC, FDA and state department of health laboratories used GenomeTrakr to match environmental and food samples with human biological samples, which helped FDA confirm the source of Listeria in an outbreak.”

Since the first state public health lab collaboration in 2012, genome sequences have been added for more than 11,000 isolated pathogens to the GenomeTrackr Database.

Sentinel Initiative

FDA recently completed its pilot “active surveillance” medical product safety monitoring program, the Mini-Sentinel, and is now rolling out the full-scale Sentinel Initiative.

The Mini-Sentinel activities focused on assessing exposures of medical products regulated by the FDA, the health outcomes, and links between them. Through the Mini Sentinel five year pilot, FDA established secure access to electronic health records (EHR) of millions of patients across the country, enabling researchers to evaluate product safety information.

Last December, Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research, announced a roll out of the Sentinel Initiative to combine EHR data with clinical analytics to provide active drug safety surveillance for the healthcare industry. “While protecting the identity of individual patients we can get valuable information from Mini-Sentinel that helps us better understand potential safety issues, and share with you information on how to use medicines safely.”