Applying proteomics to the diagnosis and treatment of ALS and related diseases.
Protein-based biomarkers for amyotrophic lateral sclerosis (ALS) and other motor neuron diseases (MNDs) have many potential clinical utilities, including diagnostic, prognostic, and drug development indications. During the past decade a number of potential protein biomarkers have been proposed for MNDs. Further verification studies, followed by large validation and qualification studies, are required to advance these initial discoveries toward clinical use. Study of additional patient populations, including disease mimics, is required during the validation phase of biomarker development. Important regulatory issues are discussed that will affect the timing and strategy for biomarker assay development in ALS and other MNDs. The continued development of protein biomarkers for MNDs requires extensive collaboration between academic clinicians and scientists in conjunction with the biotechnology and pharmaceutical industries.
Bowser
Robert
R
Department of Pathology, University of Pittsburgh School of Medicine, BST S-420, 200 Lothrop Street, Pittsburgh, Pennsylvania 15261, USA. boswerrp@upmc.edu
Lacomis
David
D
D000690:Amyotrophic Lateral Sclerosis / Q000175:diagnosis* / Q000378:metabolism / Q000628:therapy*; D000818:Animals; D015415:Biomarkers / Q000378:metabolism; D006801:Humans; D009422:Nervous System Diseases / Q000175:diagnosis / Q000378:metabolism / Q000628:therapy; D040901:Proteomics / Q000379:methods* / Q000639:trends
D015415:Biomarkers