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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.