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NIST FDA Workshop on Standards for Pathogen Detection via Next-Generation Sequencing

Workshop Report

The workshop report is available! Thanks to all who contributed to the workshop, and we look forward to updating you on mixed microbial DNA RM developments and the next workshop (early 2017).   

NIST-FDA Workshop Report

The purpose of this NIST-FDA workshop is to seek input on defining reference materials, reference data and reference methods for assessing analytical sensitivity, specificity, and relative performance of NGS-based pathogen detection devices/assays.

Description: This workshop will be targeted towards the primary users/adopters of these standards; including clinicians, the biosecurity community, public health labs, industry, academics and government laboratories.

Day 1  (Oct. 27) Will Include Talks From Subject Matter Experts on Topics Including:

  • Clinical applications of NGS for infectious disease diagnostics
  • Public health laboratory applications of NGS for culture-independent diagnostics
  • Regulatory perspectives on NGS for infectious disease diagnostic devices
  • Genomic reference materials
  • Pathogen genomic sequence databases
  • Mixed sample reference materials for biothreat detection
  • Bioinformatic analyses of shotgun metagenomic sequence data

Day 2 (Oct. 28) Will Include Break-Out Sessions Focused On:

  • The selection of pathogen constituents and their abundances for a prospective mixed DNA reference material
  • Characterization parameters for prospective mixed pathogen DNA reference material
  • A plan for crowd-sourcing and inter-laboratory studies to test the material's suitability for benchmarking precision and accuracy for pathogen detection devices/assays

Poster Session for Industry Representatives

Day two (Oct. 28th) will also include a 2 hour poster session specifically for industry representatives to demonstrate their latest technological advances for pathogen detection.

Charles Chiu MD/PhD – UCSF School of Medicine

Joseph Campos PhD – Children's National Health System

John Besser PhD – CDC

Timothy Minogue PhD – USA MRIID Diagnostic Systems

Courtyard Marriott - Washingtonian Center
204 Boardwalk Place,
Gaithersburg, MD 20878

Room block - nist-quoted price is $222 per night.

If you are not registered, you will not be allowed on site. Registered attendees will receive security and campus instructions prior to the workshop.

NON U.S. CITIZENS PLEASE NOTE: All foreign national visitors who do not have permanent resident status and who wish to register for the above meeting must supply additional information. Failure to provide this information prior to arrival will result, at a minimum, in significant delays (up to 24 hours) in entering the facility. Authority to gather this information is derived from United States Department of Commerce Department Administrative Order (DAO) number 207-12. When registration is open, the required NIST-1260 form will be available as well. *New Visitor Access Requirement: Effective July 21, 2014, Under the REAL ID Act of 2005, agencies, including NIST, can only accept a state-issued driver's license or identification card for access to federal facilities if issued by states that are REAL ID compliant or have an extension. Driver's licenses from nine states and territories are not compliant and will not be accepted as identification. Click here for a list of alternative identification and further details>>

Created September 28, 2015, Updated August 2, 2018