FDA-ARGOS is a database with public quality-controlled reference genomes for diagnostic use and regulatory science
PublisherNature Publishing Group
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AbstractFDA proactively invests in tools to support innovation of emerging technologies, such as infectious disease next generation sequencing (ID-NGS). Here, we introduce FDA-ARGOS quality-controlled reference genomes as a public database for diagnostic purposes and demonstrate its utility on the example of two use cases. We provide quality control metrics for the FDA-ARGOS genomic database resource and outline the need for genome quality gap filling in the public domain. In the first use case, we show more accurate microbial identification of Enterococcus avium from metagenomic samples with FDA-ARGOS reference genomes compared to non-curated GenBank genomes. In the second use case, we demonstrate the utility of FDA-ARGOS reference genomes for Ebola virus target sequence comparison as part of a composite validation strategy for ID-NGS diagnostic tests. The use of FDA-ARGOS as an in silico target sequence comparator tool combined with representative clinical testing could reduce the burden for completing ID-NGS clinical trials. Copyright 2019, This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.
SponsorsThis project has been funded with Federal funds from the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, Department of Health and Human Services, under Contract No. HHSF223201310109C, HHSF223201510106C, HHSF223201610073C and the Department of Defense, under Contract No. 224-15-6506R. This research was supported by the Intramural Research Program of the NIH, National Library of Medicine. This project was funded by DTRA, Contract No. CB10245.
Identifier to cite or link to this itemhttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85070609297&doi=10.1038%2fs41467-019-11306-6&partnerID=40&md5=4f402e9d5771fd7095c12056a4a17967; http://hdl.handle.net/10713/10408