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U.S. Department of Health and Human Services

About FDA

Tuberculosis Frozen Trial Repository

Description: Work closely with Global Alliance on Tuberculosis (TB) to develop a bank of biological specimens (e.g., whole blood, serum, urine, stool, cerebrospinal fluid (CSF), and tissue from other extra-pulmonary sites) obtained during clinical trials that are correlated with clinical findings and outcomes to provide crucial material for developing a spectrum of important point-of-care diagnostics and TB biomarkers. These include immunological correlates of TB vaccine protection, biomarkers for relapse, diagnostic markers for active pulmonary and extra-pulmonary TB, that are blood/CSF/urine/stool-based, point-of-care diagnostics for identifying TB infection and TB drug-resistance.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Hold stakeholder meeting to establish collaboration


Completed 12/7/2010

B. Begin collecting specimens


Completed 6/30/2011

C. Expand specimen collection to new sources including pharmaceutical sponsored trials and national treatment programs


Completed 1/27/2012

D. Define parameters for specimen availability



On Track

E. Begin making specimens available



On Track

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.


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.