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Point/Counterpoint |
1 NCI-FDA Clinical Proteomics Program, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892.
2 NCI-FDA Clinical Proteomics Program, Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, MD 20892.
aAuthor for correspondence.
| The first 300 words of the full text of this article appear below. |
Dr. Diamandis raises concerns about the technical feasibility and biological validity of using mass spectroscopy to profile serum proteomic biomarker patterns. Scientific skepticism and debate are essential to the progress of science. However, the pipeline of approved new markers is drying up (1)(2). Currently, serum proteomic pattern analysis has the potential to discover useful biomarkers faster than any existing technology. Ultimately, the deciding factor for any new diagnostic technology is true patient benefit.
Serum mass spectroscopic proteomic pattern diagnostics is a rapidly expanding field of study. Since our initial publication (3) showing the feasibility for ovarian cancer detection, other laboratories have confirmed and extended this concept (4)(5)(6)(7)(8). The growing excitement for this new approach goes far beyond the adoption of mass spectroscopy as a diagnostic instrument. Indeed, mass spectroscopy is well established as a routine clinical diagnostic tool. It has been successfully used for many years for neonatal metabolic disorder screening, where the sensitivity and reproducibility of this technology are comparable to those of other clinical assay methods (9)(10). The true scientific goal of serum proteomic pattern analysis is improved biomarker discovery.
There is a great need to discover novel biomarkers and translate them to routine clinical use (1). Conventional differential display technologies (gene arrays, two-dimensional polyacrylamide gel electrophoresis, and others), followed by antibody production, validation, and ELISA testing, are inherently costly and laborious with long cycle times between discovery and clinical implementation. The paucity of new Food and Drug Administration-approved or even "homebrew"-based analytes is driving investigators to break out of this cycle. Mass spectroscopic serum proteomic pattern analysis can sort through tens of thousands of potential biomarkers in the time it takes to read this sentence.
The following articles in journals at HighWire Press have cited this article:
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  E. P. Diamandis Oncopeptidomics: A Useful Approach for Cancer Diagnosis? Clin. Chem., June 1, 2007; 53(6): 1004 - 1006. [Full Text] [PDF]
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 E. P. Diamandis Serum Proteomic Profiling by Matrix-Assisted Laser Desorption-Ionization Time-of-Flight Mass Spectrometry for Cancer Diagnosis: Next Steps Cancer Res., June 1, 2006; 66(11): 5540 - 5541. [Full Text] [PDF]
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S. R. Master Diagnostic Proteomics: Back to Basics? Clin. Chem., August 1, 2005; 51(8): 1333 - 1334. [Full Text] [PDF]
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G. L. Hortin and B. Meilinger Cross-Reactivity of Amino Acids and Other Compounds in the Biuret Reaction: Interference with Urinary Peptide Measurements Clin. Chem., August 1, 2005; 51(8): 1411 - 1419. [Abstract] [Full Text] [PDF]
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 J. Listgarten and A. Emili Statistical and Computational Methods for Comparative Proteomic Profiling Using Liquid Chromatography-Tandem Mass Spectrometry Mol. Cell. Proteomics, April 1, 2005; 4(4): 419 - 434. [Abstract] [Full Text] [PDF]
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G. L. Hortin Can Mass Spectrometric Protein Profiling Meet Desired Standards of Clinical Laboratory Practice? Clin. Chem., January 1, 2005; 51(1): 3 - 5. [Full Text] [PDF]
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S. K. Drake, R. A.R. Bowen, A. T. Remaley, and G. L. Hortin Potential Interferences from Blood Collection Tubes in Mass Spectrometric Analyses of Serum Polypeptides Clin. Chem., December 1, 2004; 50(12): 2398 - 2401. [Full Text] [PDF]
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W. E. Grizzle, S. Meleth, E. F. Petricoin, and L. A. Liotta Clarification in the Point/Counterpoint Discussion Related to Surface-Enhanced Laser Desorption/Ionization Time-of-Flight Mass Spectrometric Identification of Patients with Adenocarcinomas of the Prostate * Proteomic Pattern Complexity Reveals a Rich and Uncharted Continent of Biomarkers Clin. Chem., August 1, 2004; 50(8): 1475 - 1477. [Full Text] [PDF]
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 J. Hirsch, K. C. Hansen, A. L. Burlingame, and M. A. Matthay Proteomics: current techniques and potential applications to lung disease Am J Physiol Lung Cell Mol Physiol, July 1, 2004; 287(1): L1 - L23. [Abstract] [Full Text] [PDF]
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E. P. Diamandis Mass Spectrometry as a Diagnostic and a Cancer Biomarker Discovery Tool: Opportunities and Potential Limitations Mol. Cell. Proteomics, April 1, 2004; 3(4): 367 - 378. [Abstract] [Full Text] [PDF]
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 E. P. Diamandis Analysis of Serum Proteomic Patterns for Early Cancer Diagnosis: Drawing Attention to Potential Problems J Natl Cancer Inst, March 3, 2004; 96(5): 353 - 356. [Full Text] [PDF]
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 E. F. Petricoin, V. Rajapaske, E. H. Herman, A. M. Arekani, S. Ross, D. Johann, A. Knapton, J. Zhang, B. A. Hitt, T. P. Conrads, et al. Toxicoproteomics: Serum Proteomic Pattern Diagnostics for Early Detection of Drug Induced Cardiac Toxicities and Cardioprotection Toxicol Pathol, January 1, 2004; 32(1_suppl): 122 - 130. [Abstract] [PDF]
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