A tuberculosis biomarker database: the key to novel TB diagnostics.

New diagnostic innovations for tuberculosis (TB), including point-of-care solutions, are critical to reach the goals of the End TB Strategy. However, despite decades of research, numerous reports on new biomarker candidates, and significant investment, no well-performing, simple and rapid TB diagnostic test is yet available on the market, and the search for accurate, non-DNA biomarkers remains a priority. To help overcome this 'biomarker pipeline problem', FIND and partners are working on the development of a well-curated and user-friendly TB biomarker database. The web-based database will enable the dynamic tracking of evidence surrounding biomarker candidates in relation to target product profiles (TPPs) for needed TB diagnostics. It will be able to accommodate raw datasets and facilitate the verification of promising biomarker candidates and the identification of novel biomarker combinations. As such, the database will simplify data and knowledge sharing, empower collaboration, help in the coordination of efforts and allocation of resources, streamline the verification and validation of biomarker candidates, and ultimately lead to an accelerated translation into clinically useful tools.

[1]  Adamandia Kapopoulou,et al.  TubercuList--10 years after. , 2011, Tuberculosis.

[2]  T. Ottenhoff,et al.  A Helicopter Perspective on TB Biomarkers: Pathway and Process Based Analysis of Gene Expression Data Provides New Insight into TB Pathogenesis , 2013, PloS one.

[3]  N. Dendukuri,et al.  Quality and Reporting of Diagnostic Accuracy Studies in TB, HIV and Malaria: Evaluation Using QUADAS and STARD Standards , 2009, PloS one.

[4]  L. Coin,et al.  Diagnosis of childhood tuberculosis and host RNA expression in Africa. , 2014, The New England journal of medicine.

[5]  C. Karp,et al.  Transformative tools for tackling tuberculosis , 2015, The Journal of experimental medicine.

[6]  Madhukar Pai,et al.  Development, roll-out and impact of Xpert MTB/RIF for tuberculosis: what lessons have we learnt and how can we do better? , 2016, European Respiratory Journal.

[7]  D. Rennie,et al.  The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. , 2003, Annals of internal medicine.

[8]  Susan Mallett,et al.  QUADAS-2: A Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies , 2011, Annals of Internal Medicine.

[9]  N. Anderson,et al.  The Human Plasma Proteome , 2002, Molecular & Cellular Proteomics.

[10]  George M Church,et al.  Tuberculosis Drug Resistance Mutation Database , 2009, PLoS medicine.

[11]  Purvesh Khatri,et al.  Genome-wide expression for diagnosis of pulmonary tuberculosis: a multicohort analysis. , 2016, The Lancet. Respiratory medicine.

[12]  N. Dendukuri,et al.  Commercial Serological Tests for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis: An Updated Systematic Review and Meta-Analysis , 2011, PLoS medicine.

[13]  Madhukar Pai,et al.  Research Questions and Priorities for Tuberculosis: A Survey of Published Systematic Reviews and Meta-Analyses , 2012, PloS one.

[14]  G. Poste.  Bring on the biomarkers , 2011, Nature.

[15]  Elizabeth Warren.  Strengthening Research through Data Sharing. , 2016, The New England journal of medicine.

[16]  M. Pai,et al.  Tuberculosis diagnostics: which target product profiles should be prioritised? , 2014, European Respiratory Journal.

[17]  Daniel E. Zak,et al.  A prospective blood RNA signature for tuberculosis disease risk , 2016, The Lancet.

[18]  Delia Goletti,et al.  Tuberculosis Biomarkers: From Diagnosis to Protection , 2016, Infectious disease reports.

[19]  V. Pascual,et al.  Transcriptional Blood Signatures Distinguish Pulmonary Tuberculosis, Pulmonary Sarcoidosis, Pneumonias and Lung Cancers , 2013, PloS one.

[20]  A. Kesselheim,et al.  Countering imprecision in precision medicine , 2016, Science.

[21]  Observational Studies: Getting Clear about Transparency , 2014, PLoS medicine.

[22]  K. Steingart,et al.  Commercial Serological Antibody Detection Tests for the Diagnosis of Pulmonary Tuberculosis: A Systematic Review , 2007, PLoS medicine.

[23]  Steven A Carr,et al.  Protein biomarker discovery and validation: the long and uncertain path to clinical utility , 2006, Nature Biotechnology.

[24]  Stewart T. Cole,et al.  TubercuList e 10 years after , 2011 .

[25]  C. Ball,et al.  TB database 2010: overview and update. , 2010, Tuberculosis.