Counterpoint the Vision for a New Diagnostic Paradigm (Point/Counterpoint‪)‬

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 (4-8). 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.