Regulatory Considerations for Clinical Mass Spectrometry: Multiple Reaction Monitoring

Clinical proteomics provides valuable information to the study of diseases at the molecular level, with the potential to discover biomarkers for disease states. The discovery of protein/peptide signatures leaked by cancerous tumors into clinically accessible fluids could possibly lead to developing quantitative assays for diagnosing cancer early. Despite having over 1,200 cancer-related protein biomarker candidates published in the scientific literature,(1) the rate of introduction of new protein biomarkers to market as approved by FDA has averaged 1.5 new proteins per year for 15 years. This discrepancy points to an ineffective translation of proteomics from the bench to the bedside.