Science & Research

June 7, 2010 TB Public Workshop Slides, Video and Transcript

Advancing the Development of Diagnostic Tests
and Biomarkers for Tuberculosis

Sponsored by FDA, CDC, and NIAID
June 7-8, 2010, National Labor College, Silver Spring, Maryland 20903

For the workshop slides go to the docket at
Document Type: Select 'Other'. Keyword or ID: FDA-2010-N-0156

Workshop Transcript

Workshop Videos are posted below:

June 7, 2010 Morning session

June 7, 2010 Afternoon Session

June 8, 2010 Morning Session

June 8, 2010 Afternoon Session

June 8, 2010 Afternoon Summation

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The Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and National Institute of Allergy and Infectious Diseases (NIAID) jointly sponsored a workshop that addressed 2009 Federal Tuberculosis Task Force recommendations to develop strategies for expedited discovery, evaluation, and implementation of new rapid methods for laboratory confirmation of Tuberculosis (TB) and identification of drug resistant TB.

These recommendations were made in response to the current need for validated diagnostic tests and biomarkers that address critical issues in TB research, clinical care, and control, including:

  • The detection of pulmonary TB in adults and presence of resistance mutations
  • The detection of extrapulmonary TB
  • Predicting possible relapse during or following treatment of TB
  • Predicting vaccine efficacy
  • The detection of latent TB infection

Discussion topics included:

  • Background, Current Research, and Barriers: P. Della-Latta , R. Chaisson, J. Belisle, M. Giovanni
  • Regulatory Perspectives on the Development of New TB Diagnostics: S. Hojvat, M. Powell
  • Resources for Developing New TB Diagnostics: B. Mulach, J. Gheuens, B. Nikolic, S. Dorman, J. Ellner, A. Luetkemeyer
  • Components of/requirements for a TB Repository: A. Ramsay, M. Guillerm, D. Dixon
  • Perspective on the Development of TB Diagnostics and Biomarkers: V. Jonas, D. Persing, D. McNeely, M. Perkins, P. Small
  • Panel Discussion: M. Spigelman, P. Small, M. Perkins, (partial list)

Conveners: Leonard Sacks (FDA), Bonnie Plikaytis, (CDC), and Christine Sizemore (NIAID)

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