jueves, 23 de marzo de 2017

CDRH Industry: The FDA is Seeking Microbial Genomes Submissions to FDA-ARGOS Database

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Today the U.S. Food and Drug Administration (FDA) published a new webpage to promote the advancement of Infectious Disease Next Generation Sequencing (ID-NGS) technology. 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 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. At this time, there is no FDA approved ID- NGS device.
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, the FDA, in collaboration with the Department of Defense, the Institute for Genome Sciences at the University of Maryland and the National Center for Biotechnology Information established a publicly available public health resource known as FDA- ARGOS (dAtabase for Reference Grade micrObial Sequences). This database contains quality controlled and curated genomic sequence data from a variety of infectious microorganisms for clinical evaluations to support research and regulatory decisions. This evolving database could be used as a tool for in-silico (computer simulation) performance validation.
The FDA-ARGOS team openly invites additional collaborators from the scientific community to assist in filling the gaps in this public resource. We are specifically searching for unique, hard to source microbes such as biothreat organisms, emerging pathogens, and clinically significant bacterial, viral, fungal, and parasitic genomes. The goal is to collect geographically and historically diverse sequence information for a minimum of 5 isolates per species.
If you have questions about FDA-ARGOS, including how to contribute samples, or to qualify existing genomes by the FDA, please email FDA-ARGOS@fda.hhs.gov.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

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