About FDA
GenomeTrakr Program
Description: The GenomeTrakr Program is creating a sustainable network of public health laboratories using whole genome sequencing (WGS) to investigate foodborne illness outbreaks and attribute illnesses to specific food products, processing or farming practices, or geographic regions. The program is changing the way that foodborne illnesses are investigated, allowing authorities to investigate small illness clusters before there is a chance to sicken large numbers of people. The network is linked by a common, publically-accessible database that uses a common sequencing platform, with common laboratory and quality control procedures, common on-board training and a common metadata (sample information) standard. Since 2012, the network has expanded to 10 state health and agriculture laboratories, one commercial lab servicing the food industry, and one international lab. The network has built a database of over 10 thousand and 4 thousand Salmonella and Listeria monocytogenes genomes respectively from real time surveillance and historical collections. This database has supported multiple foodborne illness outbreak investigations and is fundamentally changing the way that outbreak investigations are conducted.
Accomplishment: As of October 1, 2018, the milestones of the GenomeTrakr network key project were completed. Work continues to harmonize international standards for Whole Genome Sequencing in collaboration with the International Standards Organization (ISO) and international organizations. These international standards continue to evolve as science and use of WGS technology advance. For more information about the GenomeTrakr program, please visit:https://www.fda.gov/food/foodscienceresearch/wholegenomesequencingprogramwgs/ucm363134.htm
Briefing Status: Completed
Prior Briefing Status: Completed
Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
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A. Develop FDA Trak-n-trace program (FDA compliance/CORE) |
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i. Develop hands-on genomic workbench to support compliance/enforcement strategies and Coordinated Outbreak Response and Evaluation (CORE) activities. |
10/31/2018 |
Completed | 10/31/2018 |
a. Develop software tools for genomic compliance workbench. |
10/31/2016 (10/31/2017) |
Completed | 11/30/2017 |
b. Test and evaluate software tools with compliance test cases. |
10/31/2017 (7/31/2018) |
Completed | 7/1/2018 |
c. Implement/deploy genomics tools for compliance/enforcement and outbreak investigations. |
10/31/2018 |
Completed | 10/31/2018 |
ii. Adapt Genomic information management system (GIMS) to employ metadata tracking to link WGS data to critical investigation metadata. |
10/31/2017 (10/31/2018) |
Completed | 7/1/2018 |
iii. Develop minimum quality control standards for state network in collaboration with CDC. |
10/31/2016 (6/30/2017) |
Completed | 6/30/2017 |
iv. Harmonize international standards for WGS in collaboration with International Organization of Standardization (ISO) and international organizations. |
10/31/2018 |
Completed | 10/1/2018 |
v. Develop international proficiency standards and program in collaboration with Global Microbial Identifier (GMI) group. |
10/31/2017 |
Completed | 9/30/2017 |
B. Develop a single WGS-based workflow for full Salmonella outbreak strain characterization. |
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i. Develop WGS Serotyping approach for Salmonella outbreak strain characterization. |
10/31/2018 |
Completed | 9/30/2017 |
a. Adapt SeqSero software to develop method for serotyping Salmonella pathogens. |
10/31/2016 (10/31/2017) |
Completed | 9/30/2017 |
b. Evaluate Seek-sero method for serotyping Salmonella pathogens. |
10/31/2017 |
Completed | 9/30/2017 |
c. Validate Seek-sero method for serotyping Salmonella pathogens. |
10/31/2017 |
Completed | 10/31/2017 |
d. Implement/deploy Seek-sero method for serotyping Salmonella pathogens. |
10/31/2018 |
Completed | 7/15/2018 |
ii. Integrate CVM-developed WGS anti-microbial resistance (AMR) screening tool- accurate correlation analysis between AST (phenotypic) (CVM lead). |
10/31/2018 |
Completed | 8/1/2018 |
a. Validate WGS AMR/AST tool. |
10/31/2016 (12/31/2017) |
Completed | 12/31/2017 |
b. Implement/deploy WGS AMR/AST tool. |
10/31/2018 |
Completed | 8/1/2018 |
iii. Integrate WGS microbial characterization tools (i-iii) into single WGS predictive software tool for outbreak/isolate strain characterization |
10/31/2018 |
Completed | 10/1/2018 |
a. Consolidate WGS outbreak characterization scripts or plug-ins into single dashboard toolbox for pathogen characterization. |
10/31/2018 |
Completed | 10/1/2018 |
b. Implement/deploy WGS microbial characterization tool for pathogen characterization. |
10/31/2018 |
Completed | 10/1/2018 |
Key Projects Legend
Milestone Status | Definition |
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Not Yet Started | Work for specific milestone has not yet been started. |
Completed | Milestone and/or overall project is completed. |
On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |