Many infectious diseases have similar signs and symptoms, making it challenging for healthcare providers to identify the disease-causing agent. Clinical samples are often tested by multiple test methods to help reveal the particular microbe that is causing the infectious disease. The results of these test methods can help healthcare professionals determine the best treatment for patients. Today, High-Throughput Sequencing (HTS) or Next Generation Sequencing (NGS) technology has the capability, as a single test, to accomplish what might have required several different tests in the past.
NGS technology may allow the diagnosis of infections without prior knowledge of disease(s) cause. NGS technology can potentially reveal the presence of all microorganisms in a patient sample. Using infectious disease NGS (ID-NGS) technology, each microbial pathogen may be identified by its unique genomic fingerprint. 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.
A new and flexible regulatory strategy is being developed to evaluate ID-NGS diagnostic devices to help promote innovation, combat global threats and advance public health. To support this mission, FDA, in collaboration with the Department of Defense (DoD), the Institute for Genome Sciences at the University of Maryland and the National Center for Biotechnology Information (NCBI), established a public microbial reference database (FDA-ARGOS) that contains quality controlled and curated genomic sequence data to support research and regulatory decisions. This evolving database could be used as a tool for in-silico (computer simulation) performance validation. Use of FDA-ARGOS genomes for in-silico data analysis can potentially reduce the testing burden on industry for ID-NGS devices.
The purpose of this website is to provide information about FDA-ARGOS, and to support and foster the development of ID-NGS technology. The FDA will update this page with new information as appropriate.
- In Vitro Diagnostics
- Access the FDA-ARGOS Database @ NCBI
- Guidance Document: Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers - Draft Guidance for Industry and Food and Drug Administration Staff
Manuscripts and Reports
- Decoding Ebola: Next Generation Sequencing of the Ebola Genome for the FDA ARGOS Database •American Society for Microbiology (ASM) Report "Applications of Clinical Microbial Next-Generation Sequencing"
- National Institute of Standards and Technology (NIST) Report “Standards for Pathogen Detection via Next-Generation Sequencing”
- mBio Manuscript “Making the Leap from Research Laboratory to Clinic: Challenges and Opportunities for Next-Generation Sequencing in Infectious Disease Diagnostics”
- 2017 HTS Computational Standards for Regulatory Sciences Workshop Mar 16-17, NIH in Bethesda, MD, USA “A Biocompute Object For FDA-ARGOS Reference Genomes”
- 2017 Department of Homeland Security Sequencing Meeting Feb 1, Washington DC, USA “FDA’s Role and Tools for ID-NGS Diagnostics”
- 2017 Precision Medicine World Conference Jan 23-25, Silicon Valley, CA, USA “FDA’s Role and Tools for ID-NGS Diagnostics”
- 2016 Gates/Global Good NGS Meeting Oct 4, Bellevue WA, “Challenges & Opportunities for Standardized Reference Databases – FDA ARGOS” (PDF - 2.2MB)