The 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 FDA dAtabase for Reference Grade micrObial Sequences (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.
Many infectious diseases have similar signs and symptoms, making it challenging for health care 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 health care professionals determine the best treatment for patients. 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.
- Featured Publication: FDA-ARGOS is a database with public quality-controlled reference genomes for diagnostic use and regulatory science
- Poster: ARGOS-QC: A Comparative Quality Assessment Tool for Genome Assemblies, Yi Yan and Heike Sichtig, FDA Science Forum 2019
- In Vitro Diagnostics
Manuscripts and Reports
- Decoding Ebola: Next Generation Sequencing of the Ebola Genome for the FDA ARGOS Database (Archived)
- 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”