Science & Research

Genome Sequencing of Diverse Pathogens in Support of FDA-ARGOS

Performer: Genomics Resource Center (GRC), Institute for Genome Sciences, University of Maryland School of Medicine

Principal Investigator: Dr. Lisa Sadzewicz

Project Duration: 9/30/15 - 9/29/17

Regulatory Science Challenge

FDA plays a critical role in protecting the United States from emerging infectious diseases. During disease outbreaks, it is critical to have rapid tests to accurately identify the pathogen. Improved methods of detection are necessary to allow for earlier intervention steps and enable quicker action to protect public health.

Data from next-generation sequencing (NGS), a rapid and fairly inexpensive technology that analyzes an organism’s entire genome, shows promise for improving diagnostics tests that can rapidly detect pathogens. In addition, NGS data can be used to analyze the resistance of microbes to certain drugs, providing valuable information for clinicians treating individuals infected with a given pathogen.

Despite the availability of genomic sequences for thousands of microbes, including many bacterial pathogens, significant gaps in microbial genomic sequence knowledge still exist. A comprehensive database of known microbial genome sequences is crucial for the development of diagnostics relying on NGS technology to be able to accurately confirm and identify pathogens.

Project Description & Goals

The goal of FDA ARGOS (dAtabase for Regulatory Grade micrObial Sequences) is to create a publicly available reference database that contains high quality genomic sequence data for infectious microorganisms. GRC will generate genome sequences of 1,380 bacterial, viral, fungal, and parasite pathogens to enhance and extend the genome sequences already available in the database.

In addition to generating genomic sequence data to fill in existing sequence information gaps, the project will deliver validated Standard Operating Procedures (SOPs) and other laboratory data to support the future evaluation and validation of the sequencing data. When completed, the database will contain necessary information to support the development of sequence-based diagnostic tests by helping FDA formulate a quality standard for diagnostic applications and enabling regulatory evaluation of innovative emerging technologies.

Page Last Updated: 02/13/2017
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