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Analytical Validation Considerations of Multiplex Mass-Spectrometry-Based Proteomic Platforms for Measuring Protein Biomarkers

Boja, Emily S.; Fehniger, Thomas LU ; Baker, Mark S.; Marko-Varga, György LU and Rodriguez, Henry (2014) In Journal of Proteome Research 13(12). p.5325-5332
Abstract
Protein biomarker discovery and validation in current omics era are vital for healthcare professionals to improve diagnosis, detect cancers at an early stage, identify the likelihood of cancer recurrence, stratify stages with differential survival outcomes, and monitor therapeutic responses. The success of such biomarkers would have a huge impact on how we improve the diagnosis and treatment of patients and alleviate the financial burden of healthcare systems. In the past, the genomics community (mostly through large-scale, deep genomic sequencing technologies) has been steadily improving our understanding of the molecular basis of disease, with a number of biomarker panels already authorized by the U.S. Food and Drug Administration (FDA)... (More)
Protein biomarker discovery and validation in current omics era are vital for healthcare professionals to improve diagnosis, detect cancers at an early stage, identify the likelihood of cancer recurrence, stratify stages with differential survival outcomes, and monitor therapeutic responses. The success of such biomarkers would have a huge impact on how we improve the diagnosis and treatment of patients and alleviate the financial burden of healthcare systems. In the past, the genomics community (mostly through large-scale, deep genomic sequencing technologies) has been steadily improving our understanding of the molecular basis of disease, with a number of biomarker panels already authorized by the U.S. Food and Drug Administration (FDA) for clinical use (e.g., MammaPrint, two recently cleared devices using next-generation sequencing platforms to detect DNA changes in the cystic fibrosis transmembrane conductance regulator (CFTR) gene). Clinical proteomics, on the other hand, albeit its ability to delineate the functional units of a cell, more likely driving the phenotypic differences of a disease (i.e., proteins and protein-protein interaction networks and signaling pathways underlying the disease), staggers to make a significant impact with only an average similar to 1.5 protein biomarkers per year approved by the FDA over the past 15-20 years. This statistic itself raises the concern that major roadblocks have been impeding an efficient transition of protein marker candidates in biomarker development despite major technological advances in proteomics in recent years. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
quantitative fidgeted proteomics, protein biomarker, multiplex, proteomics assays, MRM-MS, immunoassays
in
Journal of Proteome Research
volume
13
issue
12
pages
5325 - 5332
publisher
The American Chemical Society
external identifiers
  • wos:000346039400005
  • scopus:84915751027
ISSN
1535-3893
DOI
10.1021/pr500753r
language
English
LU publication?
yes
id
5ef87cc1-acb7-44b5-b5aa-68e329895bbb (old id 4957573)
date added to LUP
2015-01-28 16:04:55
date last changed
2017-09-10 03:00:54
@misc{5ef87cc1-acb7-44b5-b5aa-68e329895bbb,
  abstract     = {Protein biomarker discovery and validation in current omics era are vital for healthcare professionals to improve diagnosis, detect cancers at an early stage, identify the likelihood of cancer recurrence, stratify stages with differential survival outcomes, and monitor therapeutic responses. The success of such biomarkers would have a huge impact on how we improve the diagnosis and treatment of patients and alleviate the financial burden of healthcare systems. In the past, the genomics community (mostly through large-scale, deep genomic sequencing technologies) has been steadily improving our understanding of the molecular basis of disease, with a number of biomarker panels already authorized by the U.S. Food and Drug Administration (FDA) for clinical use (e.g., MammaPrint, two recently cleared devices using next-generation sequencing platforms to detect DNA changes in the cystic fibrosis transmembrane conductance regulator (CFTR) gene). Clinical proteomics, on the other hand, albeit its ability to delineate the functional units of a cell, more likely driving the phenotypic differences of a disease (i.e., proteins and protein-protein interaction networks and signaling pathways underlying the disease), staggers to make a significant impact with only an average similar to 1.5 protein biomarkers per year approved by the FDA over the past 15-20 years. This statistic itself raises the concern that major roadblocks have been impeding an efficient transition of protein marker candidates in biomarker development despite major technological advances in proteomics in recent years.},
  author       = {Boja, Emily S. and Fehniger, Thomas and Baker, Mark S. and Marko-Varga, György and Rodriguez, Henry},
  issn         = {1535-3893},
  keyword      = {quantitative fidgeted proteomics,protein biomarker,multiplex,proteomics assays,MRM-MS,immunoassays},
  language     = {eng},
  number       = {12},
  pages        = {5325--5332},
  publisher    = {The American Chemical Society},
  series       = {Journal of Proteome Research},
  title        = {Analytical Validation Considerations of Multiplex Mass-Spectrometry-Based Proteomic Platforms for Measuring Protein Biomarkers},
  url          = {http://dx.doi.org/10.1021/pr500753r},
  volume       = {13},
  year         = {2014},
}