Abstract
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 general hypothesis is that patterns of low-molecular-mass biomarkers in …
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