Please use this identifier to cite or link to this item: https://hdl.handle.net/11000/30538

Diagnostic Biomarkers: Are We Moving from Discovery to Clinical Application?


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Title:
Diagnostic Biomarkers: Are We Moving from Discovery to Clinical Application?
Authors:
Parker, Lucy Anne  
Chilet Rosell, Elisa  
Hernández-Aguado, Ildefonso  
Pastor-Valero, Maria  
Gea, Sonia
Lumbreras, Blanca  
Editor:
Oxford University Press
Department:
Departamentos de la UMH::Salud Pública, Historia de la Ciencia y Ginecología
Issue Date:
2018-11
URI:
https://hdl.handle.net/11000/30538
Abstract:
Despite considerable research investment, moving from biomarker discovery to clinical application has presented unique challenges. We aimed to evaluate progress toward clinical application of a sample of molecular- and “omics”-based diagnostic tests over a 10-year period. METHODS We used Scopus to locate studies, published before the December 31, 2016, citing 107 original-research articles published in 2006 that assessed the diagnostic value of a molecular- or “omics”-based test. We identified diagnostic studies of the same test and disease and determined whether the article represented progress in the validation of the molecular test. We classified the types of progress: (a) clinical validation (measuring diagnostic accuracy in a series of patients similar to the population in which the test will be used in practice), (b) technical improvement, (c) extended diagnostic application (modification of the diagnostic question attended initially by the test), (d) economic evaluation, or (e) clinical use or implementation. RESULTS In the 10-year period analyzed, 4257 articles cited the 107 diagnostic studies; 118 (2.8%) were diagnostic studies of the same test, and of these papers, 25 (21.2%) did not constitute progress toward validation of the test for use in clinical practice (potential research waste). Of the 107 molecular- or “omics”-based tests described in 2006, only 28 (26.2%) appeared to have made progress toward clinical application. Only 4 (9.1%) of 44 proteomics-based tests had made progress toward clinical application. CONCLUSIONS Articles evaluating molecular- or “omics”-based diagnostic tests are numerous in biomedical journals. Few tests have made progress toward clinical application in the 10 years following their discovery
Keywords/Subjects:
diagnostic
omics
technical improvement
Knowledge area:
CDU: Ciencias aplicadas: Medicina
Type of document:
application/pdf
Access rights:
info:eu-repo/semantics/openAccess
DOI:
https://doi.org/10.1373/clinchem.2018.292854
Appears in Collections:
Artículos Salud Pública, Historia de la Ciencia y Ginecología



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