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U.S. Department of Health and Human Services

About FDA

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Sequencing Quality Control Phase II (SEQC2)

Description: The primary objective is to develop standard analysis protocols and quality control metrics for fit-for-purpose use of Next Generation Sequencing (NGS) data to enhance regulatory science research and precision medicine. The project consists of three specific aims: (1) to develop quality metrics for reproducible NGS results from both whole genome sequencing (WGS) and targeted gene sequencing (TGS), (2) to benchmark bioinformatics methods for WGS and TGS towards the development of standard data analysis protocols, and (3) to assess the joint effects of key parameters affecting NGS results and interpretation for clinical application.

Public Health Outcome: SEQC2 is a natural extension of the SEQC project with emphasis on DNA-Seq for various applications. The SEQC2 project, with broad participation from scientists and reviewers within FDA and collaborators across the public, academic, and private sectors, is expected to help prepare FDA for the next wave of submissions of genomic data generated from the NGS technologies.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
1. Hold workshop to define the scope of project and study designs and solicit participation from community FY16 Q4
Completed 9/14/2016
2. Begin study on the specific challenges outlined by both the FDA, public and internal documents FY17 Q2
Completed 3/1/2017
3. Develop minimum sets of NGS data FY17 Q4
Completed 9/30/2017
4. Start large scale study FY18 Q2
Completed 3/1/2018
5. Complete data analysis with data generation, if needed FY19 Q2
Completed 3/30/2019
6. Obtain approval of draft manuscripts by Center Director FY20 Q2
Not Yet Started
7. Submit manuscripts to peer-reviewed journals FY20 Q3
Not Yet Started

Foot Notes

  • The dates in italics are modified milestone due dates that have been updated due to real-time delays. The milestone status reflects the current reporting quarter’s status. If a milestone is missed, the milestone will remain delayed until the milestone is completed.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

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