title: Biomarker discovery: success as a function of risk mitigation.
abstract: Protein biomarker discovery is a fascinating enterprise; however, success in terms of products for in vitro diagnostic use is sparse. New developments in mass spectrometry-based quantitative proteomics as discovery technology have opened up new avenues for this endeavor. In addition to choice of technology, sample properties, study design and validation strategy are potent pillars required for project success. The challenge for successful biomarker discovery can be described by a series of risks that need to be mitigated. This article intends to describe the major risks along with possible solutions.
authors.affiliation: a Analytics LC-MS, R&D Early Development , Centralised and Point of Care Solutions, Roche Diagnostics , Penzberg , DE , Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Weiser
mesh_terms: D015415:Biomarkers / Q000032:analysis; D035843:Biomedical Research / Q000458:organization & administration*; D040261:Harm Reduction; D006801:Humans; D013058:Mass Spectrometry / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D011506:Proteins / Q000032:analysis*; D040901:Proteomics / Q000295:instrumentation / Q000379:methods*; D012107:Research Design; D012306:Risk; D054928:Validation Studies as Topic
chemical_list: D015415:Biomarkers; D011506:Proteins
keywords: Mass spectrometry; proteomics; study design