title: The long path towards implementation of clinical proteomics: Exemplified based on CKD273.
abstract: Clinical proteomics aims at the development and the implementation of novel biomarkers that demonstrate a clear clinical benefit in the management of diseases. However, though the attention in the field is increasing and multiple articles on biomarker research are published, clinical implementation of these biomarkers is scarce. In this paper, we aim towards identifying the hurdles on the path towards implementation, and present one successful approach, based on capillary electrophoresis coupled with mass spectrometry. A panel of biomarkers identified and assessed using this approach, termed CKD273, has recently received a Letter-of-Support from the US-Food and Drug Administration (FDA), and is now implemented in the (early) management of chronic kidney disease. Based on this experience in the process towards implementation of CKD273, issues associated with implementation and suggestions how to meet these challenges are given.
authors.affiliation: Mosaiques Diagnostics GmbH, Hannover, Germany.
authors.forename: Esther
authors.initials: E
authors.lastname: Nkuipou-Kenfack
authors.affiliation: Mosaiques Diagnostics GmbH, Hannover, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Zürbig
authors.affiliation: Mosaiques Diagnostics GmbH, Hannover, Germany.|BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.
authors.forename: Harald
authors.initials: H
authors.lastname: Mischak
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000378:metabolism; D006801:Humans; D040901:Proteomics / Q000379:methods*; D051436:Renal Insufficiency, Chronic / Q000378:metabolism*
chemical_list: D015415:Biomarkers
keywords: Biomarker; CE-MS; CKD273; Clinical proteomics; Implementation