Workshop: 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).  Click here for the report.

Original Workshop Agenda

Dear Colleagues,

We cordially invite you to attend the NIST-FDA workshop entitled "Standards for Pathogen Detection via Next-Generation Sequencing" on the NIST campus in Gaithersburg, Maryland on October 27th-28th 2015.

The purpose of this 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. These reference materials will be critical in addressing the challenges associated with mixed pathogen detection in complex samples (i.e. clinical) using shotgun metagenomic sequencing and targeted resequencing (culture-independent diagnostics) approaches. This workshop will be targeted towards the primary users/adopters of these standards; including industry, academic and government laboratories.

Day 1 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 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 (28th) will also include a 2 hour poster session specifically for industry representatives to demonstrate their latest technological advances for pathogen detection.

Attendees

Attendees will include representatives from various Federal Government Agencies, Industry, Medical Institutes, and Academia. Among others, the confirmed speakers include:

Charles Chiu MD/PhD – UCSF School of Medicine
Joseph Campos PhD – Children's National Health System
Heike Sichtig PhD – FDA Center for Devices
Timothy Minogue PhD – USAMRIID Diagnostic Systems
Patrick Chain PhD – LANL Bioinformatics

Personalized invitation letters will be made available upon request.

Hope to see you all in the Fall!

Warmest Regards,

Scott Jackson (scott.jackson [at] nist.gov (scott[dot]jackson[at]nist[dot]gov))
Jason Kralj (jason.kralj [at] nist.gov (jason[dot]kralj[at]nist[dot]gov))
Heike Sichtig (Heike.Sichtig [at] fda.hhs.gov (heike[dot]sichtig[at]fda[dot]hhs[dot]gov))
Brittany Goldberg (Brittany.goldberg [at] fda.hhs.gov (brittany[dot]goldberg[at]fda[dot]hhs[dot]gov))