title: Advancing the development of diagnostic tests and biomarkers for tuberculosis.
abstract: High costs and limited returns on investment have hampered progress in developing new diagnostic tests and treatments for tuberculosis (TB). We need new biomarkers to develop assays that can rapidly, efficiently and reliably detect Mycobacterium tuberculosis infection and disease, identify drug resistance and expedite drug and vaccine development. This can only be accomplished through cross-disciplinary collaborations to facilitate access to human specimens. The Food and Drug Administration, Centers for Disease Control and Prevention, National Institutes of Health, the industry and academia experts came together in a June 2010 workshop to examine the field of TB diagnostic test development and biomarker discovery, identify areas of most urgent need and formulate strategies to address those needs.
authors.affiliation: Office of Chief Scientist, Office of Critical Path Programs, US Food and Drug Administration, Silver Spring, Maryland 20903, USA. Yuliya.Yasinskaya@fda.hhs.gov
authors.forename: Y
authors.initials: Y
authors.lastname: Yasinskaya
authors.forename: B
authors.initials: B
authors.lastname: Plikaytis
authors.forename: C
authors.initials: C
authors.lastname: Sizemore
authors.forename: L
authors.initials: L
authors.lastname: Sacks
mesh_terms: D000995:Antitubercular Agents / Q000494:pharmacology; D015415:Biomarkers / Q000378:metabolism*; D003299:Cooperative Behavior; D003955:Diagnostic Tests, Routine / Q000379:methods; D024881:Drug Resistance, Bacterial; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000302:isolation & purification*; D014376:Tuberculosis / Q000175:diagnosis* / Q000382:microbiology
chemical_list: D000995:Antitubercular Agents; D015415:Biomarkers