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# FDA Opens Infectious Disease Sequencing Web Site
- URL: https://www.fdaweb.com/fda-opens-infectious-disease-sequencing-web-site/
- Published: 2017-03-22T12:00:00.000Z
- Updated: 2026-09-14T22:13:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138270

FDA says it has launched a Web [site](https://www.fda.gov/MedicalDevices/ScienceandResearch/DatabaseforReferenceGradeMicrobialSequences/default.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) to promote advancement of infectious disease next generation sequencing (ID-NGS) technology. CDRH says that next generation sequencing may allow the diagnosis of infections without prior knowledge of disease causes. “Using ID-NGS technology, each microbial pathogen may be identified by its unique genomic fingerprint,” the Center says. “The vision of ID-NGS technology is to further improve patient care by delivering diagnostics which can help identify the microbial makeup in patient samples quickly and accurately. At this time, there is no FDA-approved ID-NGS device.”

To support efforts to develop a new and flexible regulatory strategy to evaluate ID-NGS diagnostic devices, FDA is working with the Defense Department, Institute for Genome Sciences at the University of Maryland, and the National Center for Biotechnology Information to establish a publicly available public health resources known as FDA-ARGOS (dAtabase for Reference Grade micrObial Sequences). The agency says the database contains quality controlled and curated genomic sequence data from a variety of infectious microorganisms for clinical evaluation to support research and regulatory decisions.

The FDA-ARGOS team says it is inviting additional collaborators from the scientific community to assist in filling gaps in the public resource. It says it is searching for unique, hard to source microbes such as biothreat organisms, emerging pathogens, and clinically significant bacterial, viral, fungal, and parasitic genomes. The goal, it says, is to collect geographically and historically diverse sequence information for a minimum of five isolates per species.